IA #80-04 - REVISED 9/11/97, IMPORT ALERT #80-04, "SURVEILLANCE AND DETENTION
WITHOUT PHYSICAL EXAMINATION OF SURGEON'S AND OR PATIENT EXAMINATION GLOVES -
ATTACHMENT A - 9/23/04, ATTACHMENT B - 4/15/04
(NOTE: This import alert represents the Agency's current guidance to FDA
field personnel regarding the manufacturer(s) and/or product(s) at issue. It
does not create or confer any rights for or on any person, and does not
operate to bind FDA or the public.
REASON FOR
REISSUANCE: A new procedure was developed for detention without physical
examination of gloves manufactured by firms who repeatedly
import non-compliant products.
TYPE OF ALERT: Surveillance (Physical Examination), and Detention Without
Physical Examination
PRODUCT: Surgeon's and Patient Examination Gloves
PRODUCT CODE: 80LZA, 80FMC, 80LYY, 80LZC, 80LYZ, 79KGO
PAC: 82Z003
PROBLEM: Defective per 21 CFR 800.20 - Leaks, tears, mold, embedded
foreign objects
COUNTRY: Surveillance - All Countries - (ZZ)
Detention Without Physical Examination - See Attachments (A
& B)
MANUFACTURER/
SHIPPER: See Attachments (A & B)
MANUFACTURER/
SHIPPER ID#: N/A
IMPORTER'S
ID #: N/A
CHARGE: "The article is subject to refusal of admission pursuant to
section 801(a)(3) in that it appears to contain
defects/holes [Adulteration, section 501(c).]"
When FDA has documented repeated violations, and the
manufacturer/shipper has been issued a Warning Letter and
listed in Attachment B of the Recidivist Policy describe
below, future shipments ma be detained charging the
following:
"The article is subject to refusal of admission pursuant to
section 801(a)(1) in that it appears that the methods used
in, or the facilities and controls used for, the
manufacture, packaging, storage, or installation of the
device do not conform with Good Manufacturing Practices
[Adulteration, section 501(h), Good Manufacturing Practices,
Section 520(f).]"
RECOMMENDING
OFFICE: Center for Devices and Radiological Health (CDRH)
REASON FOR
ALERT: CDRH has determined that many foreign manufacturers and
shippers of medical gloves have failed to consistently
provide medical gloves of adequate quality for distribution
in the U. S. Surgeon's and examination gloves are widely
used by health care professionals and others as a barrier to
blood-borne diseases and pathogens. Defective medical
gloves present a potential hazard to health for users as
well as patients. Therefore, continuous monitoring of these
medical gloves is needed.
GUIDANCE: Districts may detain without physical examination, all
shipments of surgeon's and patient examination gloves from
the manufacturers/shippers listed on the attachments to this
alert.
Surveillance sampling of other manufacturers/shipper's
surgeon's and patient examination gloves per the most recent
guidance is indicated.
NOTE: Because the presence of defects in medical gloves
represents a potential hazard to health, only one (1)
violative sample is needed to submit a recommendation for
detention without physical examination to the Division of
Import Operations & Policy (DIOP). DIOP has direct
reference authority for detention without physical
examination of these medical gloves. Violative medical
gloves are subject to RPM Chapter 9, Detention Without
Physical Examination, subchapter "Recommendations Based on
One Sample."
The following strategy has been established to address those
manufacturers/shippers who are found to repeatedly ship
violative medical gloves to the U.S. (recidivist firms.)
Level 1 Detention (INDICATED BY * IN ATTACHMENT A)
When a district encounters a shipment of medical gloves
which is found violative for defects by FDA analysis, the
shipment should be detained and a recommendation for
detention without physical examination should be forwarded
to DIOP, HFC-170.
If the recommendation meets current guidance, the
manufacturer/shipper will be placed on attachment "A" with a
single asterisk(*), and subsequent medical glove shipments
from that manufacturer/shipper may be detained without
physical examination under this import alert. This is
referred to as "Level 1 detention." The
manufacturer/shipper may obtain admission of subsequently
detained shipments of medical gloves by presenting evidence
that the individual shipments are not adulterated, such as
sample analyses performed by an independent testing
laboratory, following the sampling plan and test method
contained in FDA guidance.
In order for the responsible manufacturer's/shipper's name
to be removed from attachment "A," documentation should be
provided with sufficient evidence that their medical gloves
are not adulterated (for example, five consecutive non-
violative shipments analyzed as described in the preceding
paragraph may be considered adequate evidence for
manufacturers/shippers to be removed from Level 1
detention).
Level 2 Detention -- (Recidivist firms which are
currently on Level 1 detention, or which have been removed
from Level 1 detention) (INDICATED BY ** IN ATTACHMENT A)
If a manufacturer/shipper, while on Level 1 detention, has a
violative sample analyzed by a private laboratory, the
district should notify DIOP and submit supporting
documentation. DIOP will place the firm on Level 2 detention
and identify the manufacturer/shipper on attachment "A" with
two asterisks (**).
Similarly, if a manufacturer/shipper that has been removed
from Level 1 detention has a violative sample analyzed by
FDA within 24 months from the date they were removed from
Level 1 detention, the district should notify DIOP and
submit supporting documentation. DIOP will verify the
manufacturer/shipper was listed under Level 1 detention
during the past 24 months and if confirmed will place the
manufacturer/shipper on Level 2 detention and identify the
manufacturer/shipper on attachment "A" with two asterisks
(**).
DIOP will bring this action to the attention of CDRH.
Based on this second listing within 24 months, CDRH has
agreed to notify the foreign firm in writing of FDA's
concerns about potential deficiencies in the manufacturing
practices and process controls which may be affecting the
quality of the medical gloves shipped to the U.S. A copy
of the Good Manufacturing Practices (GMP) Regulations will
be provided with the letter for their information.
Once a manufacturer/shipper is placed on Level 2 detention,
FDA may need greater assurance that the medical gloves are
not adulterated before removing the manufacturer/shipper
from detention without physical examination status. For
example, 10 consecutive non-violative shipments, analyzed by
an independent testing laboratory, may be considered
adequate evidence that the manufacturer/shipper is shipping
medical gloves to the U.S. which are not adulterated. Other
types of evidence to remove the appearance of a violation
will be evaluated by CDRH on a case-by-case basis.
Level 3 Detention -- (Recidivist firms which are
currently on Level 2 detention, or which have been removed
from Level 2 detention) (** * IN ATTACHMENT A DENOTES A
WARNING LETTER IS BEING CONSIDERED BY CDRH)
If a manufacturer/shipper, while on Level 2 detention, has
another violative sample analyzed by an independent testing
laboratory, the district should notify DIOP and submit
supporting documentation.
Similarly, if a manufacturer/shipper removed from Level 2
detention has another violative sample analyzed by FDA
within 24 months from the date they were removed from Level
1 detention, or the date they were placed on Level 2
detention, DIOP will bring these instances to the attention
of CDRH.
Based on the failure of the manufacturer's/shipper's medical
gloves to pass FDA analysis [Section 501(c)] after being
listed on Level 2 detention, or having failed an independent
testing laboratory examination while under Level 2
detention, CDRH may then issue a Warning Letter to the firm.
Additionally, after reviewing the manufacturer/shipper's
export and inspectional history, CDRH may elect to charge
the firm for failure to conform with GMPs [Section 501(h)],
based on the recurring GMP deficiencies as revealed by the
repeated failures of analyses. If CDRH determines a warning
letter should issue to the foreign manufacturer/shipper,
DIOP will place the manufacturer/shipper on Level 3
detention (attachment B).
Non-violative analyses may not be sufficient to remove the
appearance of a violation for manufacturers/shippers on
attachment B. Manufacturers/shippers will remain on Level 3
detention until evidence is provided to CDRH which
demonstrates that the medical gloves are being manufacturerd
in accordance with Good Manufacturing Practices (for
example, an acceptable FDA inspection or a written
certification from the manufacturer/shipper together with
the results of an independent audit performed by a qualified
third party).
Once a foreign manufacturer/shipper satisfactorily
demonstrates that the apparent GMP deviations have been
corrected, the manufacturer/shipper will be removed from
attachment "B" and placed on attachment "A" under the Level
1 detention for individual shipment analysis to confirm
their medical gloves do not contain defects until they
provide adequate evidence to be removed from Level 1
detention (see above).
For questions or issues concerning science, science policy,
sample collection, analysis, preparation, or analytical
methodology, contact the Division of Field Science at (301)
443-3320 or 3007.
For questions concerning 21 CFR 800.20, CPG 7124.31, medical
glove labeling, or other compliance issues, contact CDRH,
Office of Compliance, Division of Enforcement II at (301)
594-4618.
SAMPLING: See 21 CFR 800.20(c) for sample plans.
All sizes should be represented as closely as feasible to
the proportion which they exist in the shipment, however,
exact statistical representation is not necessary. If the
sample is found violative, all sizes should be detained.
When an entry consists of only one size, attempt to collect
as many lot numbers as possible. For example, if during a
random sample collection three lot numbers are observed,
represent them all as subs within one sample. If the sample
is found violative, all lots should be detained.
If a shipment is detained based on the analysis of one lot
and subsequently it is learned that there were 10 lot
numbers present, the detention stands.
PRIORITIZATION
GUIDANCE: N/A
FOI: No purging is required.
KEY WORDS: Gloves, defects, surgeon's, exam gloves, holes, tears,
embedded foreign objects
PREPARED BY: Fredda Shere-Valenti, DIOP, (301) 443-6553
Diane Goldsberry, CDRH/OC/DOEII (301) 594-4618
John Farnham, CDRH/OC/DOEII (301) 594-4618
DATE LOADED
INTO FIARS: September 11, 1997 ATTACHMENT A REVISED 9/23/04
* = Firm is on Level 1 Detention
** = Firm is on Level 2 Detention
*** = Firm is on Level 3 Detention
CANADA
FORMER ADDRESS
A.R. Medicom Corp. (Shipper) Latex Examination Gloves
910 Begin Street 5/19/93
St. Laurent, Quebec H4M 2N5
Canada
FEI#: 3002324385
ID#: XQARMED910STL
NEW ADDRESS
A.R. Medicom Corp 80LYY - 10/1/98
9404 Cote de Liesse Latex Exam Gloves
Lachine, Quebec H8T 1A1
Canada
FEI#: 3002324385
Hedy Canada Latex Powdered Exam Gloves
R 1350 42nd Se Product Code: 80LYY
Calgary, Alberta T2G3V6 Class: I
MID: XAHEDCAN1320CAL 7/8/96
FEI: 3002807150
\WW Medical Supplies Inc. Vinyl Examination Gloves
219 Connie Cres, Unit #4 5/19/93
Concord, Ontario
Canada L4K 1L7
ID# XOWWMED219CON
CHINA, PEOPLE'S REPUBLIC
* Anbao Latex Factory Patient Examination Gloves
Qiange Village 80LYY
Xinzhaizi County 80LZA
Ganjing District 80LZC
Dalian, China 80LYZ
FEI# 1000254481 4/3/00
Division of:
Sinochem Liaoning Import and Export
50 Youhad Road
Dalian, China
FEI# 1000464408
Anhui Provincial Medicines & Latex Examination Gloves
Health Products 4/8/94
Import & Export Corporation
162 I\E
Shanghai, PROC
MID# CNANHPRO162ANH
MID# CNANHPRO1625SHA
Changzhou Foreign Trade Corp. Latex Examination Gloves
15 Xian Xue Street Product Code 80LYY
Changzhou, Jiangsu, China 9/20/95
MID# CNCHAFOR15CHA
MID# CNCHAFOR15JIA
FEI# 100036802
China Jiangsu Medicines and Latex examination gloves
Health Products Import and Export Corp. Product code: 80LLY
215-6 Zhongshan Street 02/20/96
Nanjing, China
FEI# 1000174806
MID# CNCHIJIA2156NAN
China Meheco Qingdao Import and Latex Examination Gloves
Export Corporation powder free
48 Zhan Shan Da Road 4/28/94
Qingdao, Peoples Republic of China
MID# CNCHIMEH48QIN
* E-Full Industrial Ltd. Latex examination gloves
No. 1, Industrial Zone 80LYY, 80LZA, 80LZC, 80LYZ,
Linqing, Shandong, China 80FMC
FEI# 3004128020 3/11/04
Fujian Ming Sheng Ind. 12/24/92
Gloves
S. Xin Shi Road
Fujian, China
MID# CNFUJMIN187SAN
aka
Sanming Foreign Trade Corp. 7/23/93
187 Xin Shi Nan Road
Sanming, Fujian
China
MID#CNSANFOR187SAN
Guilin Latex Factory Latex Examination Gloves
26 Shanghai St. Jiashan 6/9/93
Guilin, Guangxi, China (P.R.C.)
ID# CNGUILAT26GUI
Hubei Provincial Medicines Latex Examination Gloves
& Health Products Import & 5/23/94
Export Corporation
No. 196 Jingwu Road
Hankou, China
MID# CNHUBPRO196HAN
Qingdao Shuang Die Latex Latex Examination Gloves
Corporation 3/25/93
103 Tai Dong First Rd.
Qingdao, China
ID# CNQINSHU103QIN
Shangdong Medicines & Health Products Latex Examination Gloves
Import & Export Corporation 4/8/94
Qingdao, PROC
MID# CNSHAMEDQIN
Shanghai-Foxboro Co., Ltd Latex Examination Gloves
161 Caobao Road 6/9/93
Shanghai, China (P.R.C.)
ID# CNSHACO161SHA
* Shanghai Jiatai Plastic Patient Examination Gloves
Products Co., Ltd 80LYY, 80LZA, 80LZC
No. 6 New District 80LZA, 80FMC
Zhu Hang Chen 9/5/03
Jinshan Hsien
Shanghai, China
FEI# 3003010696
Shanghai Latex Factory Latex Examination Gloves
Changzheng, China PRODUCT CODE
FEI# 1000360789 80LYY
MID# CNSHALATCHA 7/6/95
Shanghai Medicines & Health Proudcts Latex Examination Gloves
27 Zhongsan Road 4/8/94
Shanghai, PROC
MID# CNSHAMED27SHA
Shanghai Strong Plastic Vinyl Examination Gloves
Products Co., Ltd. 3/25/93
Dongjing Town, Songjiang County
Shanghai, China
ID# CNSHASTRSON
** Shanghai Walnut Latex Latex Examination Gloves
Products Co., Ltd. 80LYY
1700 Huangxing Road 8/10/98
Shanghai, China (Mainland)
FEI# 1000435246
* Shanghai Foremost Plastic Sensi-flex Vinyl Exam Gloves/80LLY
Indusrial Co., Ltd. 80LZA, 80FMC, 80LYZ, 80LZC, 80NPC,
Yanli River Bridge East 80NPD & 79KGO
Chexing Highway 09/22/04
Chedun Town
Songjiang County
Shanhai 201611,
China (Mainland)
FEI #3003852635
Shijiazhuang Brilliant Ocean Vinyl Exam Gloves/ (Powdered & Powder
Plastic Company Ltd. Free) 80LYY, 80LZA, 80FMC, 80LYZ, 80LZC,
Century Industry Garden 80NPC, 80NPD & 79KGO
Shangzhuang 09/22/04
Hebei, China (Mainline)
FEI #3004532785
* Shijiazhuang Dilly Plastics Examination Gloves
Product Co., Ltd. 80FMC, 80LYY, 80LYZ, 80LZA
No. 5 Zhuangyuan Road 80LZC
Luquan City 2/26/04
Shijiazhuang, China
FEI# 3004134857
* Sinochem Hebei Vinyl Examination Gloves
Import/Export Corp. (Powdered)
No. 228, 2nd Section Product Code: 80LYZ
Heping W. Road 11/25/98
Shijiazhuang, China
FEI#: 1000640024
Tianjin Tang Gu Latex Factory Patient Latex
Tang Gu, Tianjin Examination Gloves/
Peoples Republic of China 80FMC, 80LYY
MID# CNTIATANTIA 9/27/95
FEI# 3675
Wuxi Resin Gloves Factory Vinyl Examination Gloves
Houqiao 3/25/93
Wuxi, Jingsu 214106, China
ID# CNWUXRESWUX
Zhangjiagang Fululia Latex Exam Gloves (Powdered
Rubber Plastic Co. Ltd and Powder Free)
Xizhang Town Zhangjiagang City Product Code: 80LYY
Jiangsu Province Class: I
China 7/8/96
MID#: CNZHAFULJIA
FEI#: 1000185441
Zhangjiagang Green Plastic Vinyl Examination Gloves
Products Co. Product Code: 80LYZ
Xizhang Town Zhangsiagang City Class I
Jiangsu Province 6/13/97
China
FEI#: 1000573776
*Zi Bo Wang Plastic & Rubber Products Co. Ltd Vinyl Exam Gloves
Liwang Village, Zhoujia Town 80LYZ, 80LZC, 80LYY
Huantai County 80FMC, 80LZA
Zibo City, Shandong 4/16/03
FEI: 3003851053
DENMARK
Danpren Gloves A/S All Surgical Gloves
Roholmusvej 15 6/20/94
DK 2620
Albertslund, Denmark
HONG KONG
Asino Industrial Company Latex Exam Gloves
Room 203 Hing Wah Industrial Building 6/20/94
Hi Yip Street
Yuen Long, Hong Kong
Chun Yip Plastics Ltd. Polyethylene Exam Gloves
603-609 Castle Peak Road 6/10/93
Tsuen Wan, Hong Kong
ID# HKCHUYIP6036TSE
Chung Yee Industries Limited (Shpr) Latex Examination
No. 1 Great George Street 6/9/93
Island Centre,
Causeway Bay, Hong Kong
ID# HKCHUYEE1CAU
Cico Engineering Co., Ltd. (Shipper) Latex Examination Gloves
63 Mody Road (Manufactured in China,
Tusa Sha Tsui Manufacturer Unknown)
Kowloon, Hong Kong 3/25/93
ID# HKCICENG63TUS
David Trading Co. Gloves
17 D Verdant Court 2/21/92
Discovery Bay, Hong Kong
David Trading Co. Gloves
171-172 Gloucester Road 2/21/92
Hong Kong, Hong Kong
* General Merchandise Company Latex Examination Gloves
Units 1-7, 17-20 80LYY, 80FMC, 80LYZ,
3/F Kar Wah Industrail Bldg 80LZA, 80LZC
Hei Yip Street, 7/18/00
Yuen Long, Hong Kong
FEI #3003061833
Guangzhou Rubber Goods Factory Patient Examination Gloves
aka E-Full Industrial Ltd. Product Codes:80LYY, 80FMC,
1/F., Yeung Yiu Chung No. 3 80LYZ, 80LZA, 80LZC
Industrial Building, 20 Wang Hoi Road 9/8/99
Kowloon Bay, Hong Kong
FEI# 7576
FEI# 3002423344
Hale Sun Inc. Vinyl Examination Gloves
Abba Commercial Centre 8/5/93
Aberdeen Main Road (Shipper For Trans Ancient
Hong Kong Trading Co., Taiwan)
MID# HKHALSUNHON
* Protective Industrial Products Patient Examination Gloves
Manufactory Ltd. 80LYY
Flat 1-11, 6F, Kar Wah Industrial Bldg. 10/4/99
Y.L.T.L. 356
Yuen Long, N.T.
Hong Kong
FEI# 3002816627
Ricehill Enterprises Ltd. (Distributor)
703, Sincere Building
173 Des Voeux Road
Central, Hong Kong
ID# HKRICENT703CEN
Sonley Glove Manufacturer (Factory) Latex Examination Gloves
Units Nos. 1-7, 17-20 3/25/93
3/FL Kar Wah Industrial Bldg.
Hei Yip Street
Tuen Long Nt, Hong Kong
ID# HKSONGLO1720TUE
Sonley Glove Manufacturer (Office)
178/Fl Best-o-Best Comercial
Centre 32-36, Ferry Street
P.O. Box 74281, Kowloon,
Central Hong Kong
ID# HKSONGLO7428KOW
INDIA
Asian Latex Limited Latex Exam Gloves
Yogeshwar 11/27/96
M-2 Connaught Place 80LYY
New Delhi 110001
India
FEI# 1000156445
MID# INASILAT2NEW
Beekay Hygiene Products Latex Examination Gloves
Unit of Bakhtawar Singh Balkrishan Ltd. 3/25/93
446 Sector-C
Uria Industrial Area
Raipur 493 221, India
ID# INBEEHYG446RAI
Bright Rubber Industries (P) Ltd. Latex Examination Gloves
B 80-84, Sector 8 12/3/93
Noida-201301 (Ghaziabad) U.P.
India
MID# INBRIRUB8084NOI
Digiflex India Limited Latex Exam Gloves
55 & 58 D, N.E.P.Z., Nodia 80LYY
Ghaziabad, (U.P.) 1/24/97
India
FEI# 1000146803
ID# INDIGIND55NOI
* Fitco India Latex Examination Gloves
1 Skyline Habitat 80LYY
Kochi, India 682030 6/3/98
FEI# 3001132666
(M/S Glove (India Pvt. Ltd.) Latex examination gloves
C-7 M.E.P.Z.
Tambaram, Madras, India 7/29/92
ID# INMSGLO7TAM
Goodluck Marketing Private Limited Powdered Latex
Examination Gloves 5/12/97
106, Harikrupa Chambers PRODUCT CODE: 80LYY
B/D National Chambers, Ashram Road
Ahmedabad - 380 009
Gujarat, INDIA
FEI# 1000631370
Gujarat Health Care, Ltd. Latex Examination Gloves
Village Masma, Tal: Olpad Product Code: 80LYY
Surat, Gujarat, India 11/07/95
FEI# 1000435495
MID# INGUJHEASUR
M/S. Kerala Rubbers & Reclaims (P) Ltd. Latex Examination Gloves
21, Cochin Export Processing Zone 3/25/93
Cochin, Kerala, India
ID# INMSKER21COC
Overseas Latex Pvt. Ltd. Latex examination Gloves
Plot No. 5 5/5/93
Cochin Export Processing Zone
Cochin, India
ID# INOVELAT5COC
OFFICE:
Perfect Latex Pvt. Ltd. 12/3/93
A-1, Preet Vihar
Delhi-110092, India
MID# INPERLAT1DEL
FACTORY:
Perfect Latex Pvt. Ltd. Latex Examination Gloves
23, NEPZ, NOIDA, 20135, U.P. (non-sterile)
India 12/3/93
MID# INPERLAT23NOI
Bombay, India
MID# INUNILAT402BOM
RFB Latex Private Limited 7/21/92
Plot 24, Noida Export Processing Zone
Noida-Dadri Rd., Phase II, Dist T
Gautam Budh Nagar, India
FEI# 3002808012
Sai Latex Private Limited Latex Examination Gloves
Plot Nos. A-5, 6,7 Madras Export 9/16/94
Processing Zone
Tambaram, Madras - 600 045, India
Techni Bharathi Exports (Shipper)
Palackal Buildings
Premier Junction
Kalamassery 683
104 Cochin, Kerala, India
ID# INTECBHA683COC
Zoetic Polymers Pvt. Ltd. Latex examination gloves
Plot 18, Cochin Export 2/3/93
Kakkana, Cochin, India 682-030
INDONESIA
* Indoraya Everlast Latex Exam Gloves, Powdered
Jl Jend Sudirman Kav 25 80LYY
Jakarta, Indonesia 5/28/98
FEI# 1000617827
Marganirmala Latex Examination Gloves
Jarkata, Indonesia 6/9/93
ID# IDMARJAR
P.T. Daifatex Indah Latex Examination Gloves
J.L. Cirangrang Barat 188 3/25/93
Bandung, Indonesia
ID# IDPTDAI188BAN
P.T. Dwilatex Glovindo Vinyl Exam Gloves
JL. H.O.B. Cokroaminoto No. 221 10/5/93
Yogyakarta, Indonesia
PT Indolex Karya Jakarta Latex Examination Gloves
Krekot Jaya Molek Blok E/10 4/8/94
Jakarta Pusat, Indonesia
MID# IDPTIND10JAK
Factory:
JI. Industry Raya IV
Blok Ad No. 218
Jatake Tangerang, Indonesia
MID# IDJIIND218JAT
P.T. Indotama Megah Indah
Rubber, Indonesia
P.T. Kareisindo Marga Nirmala Latex Examination Gloves
J1 Raya Pandaan Km. No. 43
Surabaya, Indonesia
ID# IDPTKAR43SUR
* P.T. Saptindo Surgical Sterile Latex Surgical Gloves
Saptindo Surgica P.T. Product Code: 79KGO
Parman Kav 12slipi Class I
Jakarta, Indonesia 11/18/97
FEI#: 1000397725
PT Surya Milani Plastic Utama Latex Examination Gloves
Gedung Perkantoran Central Bungur 80LYY
JL Bungur Besar No 38 J 9/26/96
Jakarta Pusat, Indonesia
FEI# 1000622893
P.T. Trihasta Loka Persada Latex Examination Gloves
Jalan Kasir 2 No. 11 11/21/94
Pasar Kemis Tancerang, Indonesia
KOREA
Sung Il Industrial Co., Ltd. Latex Examination Gloves
a.k.a. Chung & Yong Co. Ltd. 10/28/92
C.P.O. Box 8578
Seoul, Korea
MID# KRSUNIL8578SEO
MID# KRCHUYON8578SEO
MALAYSIA
AEK Rubber Product SDN. BHD Latex Gloves
Lot 1919 Jalan Bukit Kemuning Product Code: 80LYY
42450 Klang, Selango Ehsan Class I
Malaysia 12/08/92
FEI#: 1000111859
* Alliance Rubber Products Sdn Bhd Patient Examination Gloves
Lot 2716 & 2720, MK7 Product Code: 80LYY, 80FMC,
Kawasan Perindustrian Bukit Panchor 80LYZ, 80LZA, 80LZC
14300 Nibong Tebal 4/15/04
Pulau Pinang, Malaysia
FEI# 3002037104
* Asia Pacific Latex Sdn Bhn All Types of Examination
Lot 12 Medan Tasek Gloves
Tasek Industrial Estate,31400 Ipoh 80LZA,80FMC,80LYZ,80LZC, &
Perak Darul Ridzuan 79KGO, 80LYY
Malaysia 7/19/04
FEI# 3003362310
Asiatic Burnet Dipped Products Latex Examination Gloves
Lot 6, Jalan P/2A 3/25/93
Bangi Industrial Estate
Darul Ehsan, Malaysia
ID# MYASIBURGDAR
* Balak Rubber Nitrile Examination Gloves
(Malaysia) SDN Berhad Product Code: 80LZA
Lot 478 & 479 Jalan 8/11/98
Simpang Balak, 4300
Kajang, Selangor Darul Ehsan
Malaysia
FEI#: 1000167546
Boston & Pacific (Malaysia)
Sdn. Bhd. 12/7/90
Kulim Industrial Estate
P.O. Box 38, 09000 Kulim
Kedah, W. Malaysia
Bright Holdings SDN BH Latex Examination Gloves
8 Jalan SS13/3a Subang JA 475 (Powder Free)
Petaling Jaya 11/3/94
Malaysia
MID# MYBRIHOL475PET
Consolex Corporation, SDN.BHD. (Shipper) 9/28/92
40000 Shah Alam
Selangor Darui Ehsan
Malaysia
Clydesdale Industries SDN BHD Latex Examination
Lot 478, Jalan Simpang Balak Gloves - Powder Free
Off Batu 13, Jalan Cheras Product Code: 80LYY
43000 Kajang, Selangor D.E. 3/4/97
Malaysia
FEI# 1000414801
MID# MYCLYIND478KAJ
* Cymun Development Sdn. Bhd. Nitrile Examination
Lot 32674 Batu 3 Jalan Jelapang Gloves
Perak, Malaysia 31200 79KGO, 80FMC, 80LZC
FEI #3003662661 2/10/03
Dispotex Industries Sdn. Bhd. Latex exam gloves
No. 13, Jalan Tandang 80LYY
46050 Petaling Jaya 12/18/95
Selangor Darul Ehsan
Malaysia
FEI# 1000303848
ID# MYDISIND13PET
EAC Rubber Company M SDN BHD Latex Examination Gloves
a Subsidiary of the East Atlantic Co. 2/14/94
1A Jalan 205
46050 Petaling Jaya
Malaysia
MID# MYEACRUB205PET
Formtex Medical SDN. DHD. Latex Examination Gloves
Klang Product Code: 80LYY
Malaysia 7/21/97
FEI# 3000273853
FEI# 3000283278
Ganda Yakin SDN. BHD Latex Examination Gloves
Suite 18B, 18th Floor, Office Tower 3/25/93
Kompleks Nagaria, Malaysia
ID# MYGANYAK18KUA
ID# MYGANYAKUNK
* Ganz Industries Sdn. Bhd. Latex Examination Gloves
46-B Jalan Desa Baktitanam Desa Powder-Free
off Jalan Kelang Lamma Product Code: 80LYY
Kuala Lumpur 3/11/99
Malaysia
FEI# 3000193727
* Handsafe Products Sdn. Bhd. Powder free latex examination
Lot 6021, Kawasan Perindustrian gloves 80LYY, 80LZA, 80LZC,
Bukit Kakri, Muar, 80LYZ, 80FMC
Johor, 84200, Malaysia 3/25/04
FEI# 1000604230
* Highactive Sdn Bhd Patient Examination Gloves
Lot 12-B, Industrial Area, Product Codes:80LYY, 80FMC,
6 1/2 Miles 80LYZ, 80LZA, 80LZC
Jalan Kapong 2/17/00
52000 Kuala Lumpur
Malaysia
FEI# 3002853663
* HWA TEH Industrial Sdn. Bhd. Patient Examination
Division Street Lot 187, Sungai Dahar Gloves (Latex)
Batang Berjuntai, Malaysia 45600 80FMC, 80LYY
FEI# 3002820203 2/24/03
** Influx Pacific SDN BHD Latex Examination Gloves
Lot 61 Air Keroh Ind Est Powder Free - 3/22/94
Melaka Powdered - 4/3/98
Malaysia 75720 80FMC, 80LYY
MID# MYINFPAC61MEL Level 2 ** Detention 2/3/99
MID# MYINFMAN61MAL
MID# MYINFPAC7572MAL
FEI# 1000144099
* JK Rubber Products Sdn. Bhd. Surgical/Patient Examination
Lot 2247D, Jalan Sengkang, Sengkang Gloves
81000 Lulai, Johore, W. Malaysia 80FMC, 80LZA, 80LZC,
FEI# 3003304948 80L[][]YY, 80L[][]YZ
7/3/01
** Malyasian Healthcare Sdn Bhd Patient Examination Gloves
No. 34 Jalan PJS 11/7 80LYY, 80FMC, 80LYZ, 80LZA
Bandar Sunway 80LZC
46150 Petaling Jaya 12/6/00
Selangor, Malaysia
FEI# 3002646488
* Poly Arena Sdn. Bhd Patient Examination Gloves
No. 24, Jalan Jasmine 5 80LYY, 80FMC, 80LZA, 80LZC
Tasman Jasmine 80LYZ
23000 Kajang Selangor Darul Ehsan 8/7/00
Malaysia
FEI# 3003020590
Powercrest (M) SDN. BHD. Latex Examination Gloves
Lot 975, 3rd Mile, Jalan Kapar Product Codes: 80FMC,
P.O. Box 75, 41700 Klang 80LYY
Selangor, Malaysia Class I
MID# MYPOWSDN4170SEL
FEI# 1000311910
* Protection Gloves Sdn. Bhd. Latex Examination Gloves
Lot No. 236, Batu 2 1/2 80FMC, 80LYY, 80LZC,
Jalan Yong Pang 80LZA, 80LYZ
Jokor, Malaysia 11/6/03
FEI# 3001735646
* Seltom Pacific Sdn. Bhd. Patient Examination Gloves
Lot PT 153 80FMC, 80LZA, 80LYZ, 80LZC,
Kawasan Perusahaan Beranang 80LYY
Mukim Beranang 6/27/02
Selangor, Malaysia 43700
FEI# 3003655267 Address Change
9/23/04
* Shiraishi (Malaysia) SDN BHD Powder Free Latex Exam Gloves
17-3 Jolan 14/22 80LYY, 80LZA, 80FMC, 80LZC
The Right Angle 80LYZ
46100 Petaling Jaya, 10/28/03
Selangor, Malaysia
FEI #3003534526
Sinetimed Latex SDN. BHD Latex Examination Gloves
Lot 57 & 8, Lorang Kilang 15 (Powdered)
Tupai Light Industrial Area Product Codes: 80LYY & 80FMC
34000 Taiping, Perak Class I
Malaysia 6/6/97
FEI#: 1000212624
South Pacific Chemical Industries Latex examination
SDN BHD Gloves
No. 64-66, 2nd Floor, 2/3/93
Bangunan Jurukur
Jalan 52/4, 46200 Petaling Jaya
Darul Ehsan
Selangor, Malaysia
ID# MYSOUPAC4620DAR
Stermed Industries SDN Bhd Latex Examination Gloves
Lot 4209, Jalan Bakariah PRODUCT CODE
Johor 84000 80LYY
Malaysia 7/21/95
FEI# 1000251953
MID# MYSTEIND8400JOH
Taiping Naga Rubbex Latex exam gloves
Loy 6706, Jaln Sekolan, 12/08/92
Rantau Panjang, 3 3/4 miles,
Jalan Kapar 41400
Kelang, Selangor Dakul Ehsan,
Malaysia
ID# MYTAINAG70KEL
* Wear Safe Malaysia (WSM) Sdn. Bhd. Examination Gloves
Subsidiary of Pan-Century Rubber Products Sdn. Bhd. 80FMC, 80LYY
Lot 1, Leboh Hishamuddin Satu 80LYZ, 80LZA
North Klang Straits Industrial Area 80LZC
42000 Port Klang 7/10/03
MALAYSIA
FEI# 3002887765
# 1000198877
Wescorp Industries, SDN. BHD. (Mfr.) Latex Examination Gloves
Malaysia 9/28/92
Tri Ray SDN BHD
50000 Kuola Lupur
Malaysia
MEXICO
Derivados De Gasa* Surgeon's gloves
Avenue Henry Ford, No. 366 SEE IMPORT ALERT #89-04
Del Gustavo A. Madero 3/10/94
07850, Mexico D.F. (Mexico
City), Mexico
* Derivados De Gasa is on automatic detention under Import Alert
#89-04 for failure to meet GMP's. The firm is listed here only
to preclude inadvertant release of entries. GMP charges should
be used for detentions.
Guantes Quirurgicos S.A.* Surgeon's gloves
de C.V. Av. Centenario No. 15 SEE IMPORT ALERT #89-04
62500 Civac Jiutepec
Cuernavaca, Moreles, Mexico
* Guantes Quirurgicos S.A. is on automatic detention under Import
Alert #89-04 for failure to meet GMP's. The firm is listed here
only to preclude inadvertant release of entries. GMP charges
should be used for detentions.
* Supertex Industrial SA De CV Latex Examination Gloves
Carretera A Sosques (Powdered)
De San Isidro No. 1136 80LYY
Zapopan, Jalisco 9/14/98
Mexico SEE IMPORT ALERT #89-04
FEI# 3001166250
* Supertex Industrial SA De CV is on automatic detention under Import
Alert #89-04 for failure to meet GMP's. The firm is listed here
only to preclude inadvertant release of entries. GMP charges
should be used for detentions.
PHILIPPINES
Midas International Development Co. Latex Exam Gloves
103 E. Rodriguez Avenue 2/23/94
Ugong, Pasig, Metro Manila
Philippines
MID# PHMIDINT103MET
SINGAPORE
G. Premjee Trading Pte. Ltd.
24 Raffles Place
#25-04 Clifford Centre, Singapore 0104
ID# SGPRETRA2504SIN
SRI LANKA
Latexam Gloves (Private) Ltd. Vinyl Examination Gloves
344 Grandpass Road 4/16/93
Colombo 14, Sri Lanka
ID# LKLATGLO344COL
TAIWAN
Atico, Ltd.
Taiwan
CHC Hardware Co. Inc.
Taiwan
Chinese Product Promotion
Taiwan
Dan Co., Ltd. 9/3/92
A/K/A Dantex Glove Co 9/21/92 added
Suite 1005, No. 148 Vinyl Gloves
Section 4, Chung Hsaiao
East Road
Taipei, Taiwan
Daansen 9/3/92
Taipei, Taiwan
Daw Shin Industrial
Taiwan
1st Trust Industrial Corp
10th floor #172
Hsin_Yi Rd., Sec. 4
Taipei 10657, Taiwan
* Excellence Enterprise Co. Ltd. Patient Examination Gloves
No. 13, Chu Tsun Li 80LYY, 80LZA, 80LZC, 80FMC,
Puh Tzu City 80LYZ
Chia Yi Hsien, Taiwan R.O.C. 6/18/01
FEI# 3003123198
Evergreen Medical Plastic Exam Gloves/80LYY
Products Co. Ltd. 80LZA, 80FMC, 80LYZ, 80LZC, 80NPC,
No. 1 Evergreen Road 80NPD & 79KGO
The Nort of Beishimen Village 09/22/04
Xiaozuo Town
Jingxing County
Taiwan
FEI #3004428435
* Gain Honor Development Limited Patient Examination Gloves/
Rm. 3, 5 th. Floor, No. 78 Fushin S. Rd. 80LYZ
Sec. 1, Taipei, Taiwan, R.O.C 4/12/99
FEI# 1000655943
Goldeneyes Corp
Taiwan
** Hsing Yi Plastic Processing Co. Patient Examination Gloves
No. 108-1 Der Jia Li 80LYY
Put-Zu City 80LZA
Chia-Yi Shien 80LZC
Taiwan 80LYZ
FEI# 3001622651 5/4/00
LCL Taiwan & Co., Ltd. Latex Examination Gloves
No. 166-20 Riao-Pu-Li Matou Chen Vinyl Examination Gloves -
Tainan Hsien Taiwan R.O.C. 80LYZ
MID# TWLCLTAI1662TAI 12/11/95
Leader Well Co. Ltd.
Taiwan
Neo Sigma Inc.
Taiwan
* Sincere Medical Industrial Co. Ltd Latex Examination Gloves
Tower Bridge V. 018E (Powder Free)
Taipei, Taiwan Product Code: 80LYY,
FEI#: 1000479670 Class I, 10/22/97
Sunny-Mart Merchandise Co., Ltd. Latex Examination Gloves
Second Floor 39-1, An-Ho Road 3/25/93
Taipei, Taiwan
ID# TWSUNMER391TAI
Taiwan Disposable Products
Taiwan
Terng Nan Industrial Corp. Latex Surgeons Gloves
P O Box 53-368 3/25/93
Taipai, Taiwan
ID# TWTERNAN5336TAI
(NOTE: FIRM MAY ALSO OPERATE AT FOLLOWING ADDRESS)
9f-9, No. 112, Sec. 4, Chung Hsiao East Road
Taipai, Taiwan
ID# TWTERNAN112TAI
Topas Industrial Co
Taiwan
Tse Fong International Co., Ltd. Vinyl Examination Gloves
341 Jen Al Road, Sec. 4 10/15/92
Taipei, Taiwan
Unitech Kingdom Enterprises Co.
Taiwan
THAILAND
A.P. Rubber Co. Ltd. Latex Examination
26/2 Rajyindee Road Gloves
Hatyai, Songkhla 10/5/92
Thailand
Dr. Boo Co., Ltd. Latex Examination Gloves
Ste. # 1102-11th Fl., Powder Free
Wall St. Tower Bldg. 80LYY
33/48 Suriwong Rd. 8/4/97
Bangkok 10500, Thailand
FEI# 3307
* C. RUBBER CO., LTD. LATEX PATIENT EXAMINATION
162/2 MOO 4 GLOVES
PETEHKASAME RD. OMNO 1 80LYY, 80LZA, 80LZC, 80FMC
KRATUMBAN, SAMUTSKORN, 5/17/99
THAILAND
FEI# 1000134310
MFR.: Latex Examination Gloves
* COVCO Ltd. Powdered
A.E. House Building 200/3 Product Code: 80LYY
Ramkhamhaeng 4, Ramkhamhaeng Rd. 12/15/98
Suanluang, Bangkok 10250
Thailand
FEI#: 1000292298
Dah Lee Rubber Industries Ltd. Latex Examination Gloves
5/61 Niphutsongkraw 1 Road, 4/29/96
Soi 1 Hatyai
Songkhla 90110
Thailand
FEI# 8040989
MID# THDAHLEE561SON
Famont Company Ltd. Latex Examination Gloves
1466 Soi Chantratip Sapan 8/5/93
2 1/2 Chan Rd. Yannawa
MID# THFAMCOM1466BAN
MID# THFAMCO1466YAN
* Medtexx Industries All Types of Examination
(Thai)Co., Ltd. Gloves
200 Mu-4 Tambol Tachang 80LYY, 80FMC, 80LYZ,
Amphur Bangklam 8/5/02
Hatyai, Songkhla 90110 PRODUCT CODE CHANGE
Thailand 9/6/02
FEI# 3003107955
* Phutex Products Co., Ltd. Latex Examination
1-3-5 Krabi Road, Muang Phuket Gloves
Phuket, Thailand 83000 80LYY
FEI# 1000333397 1/26/98
TK Glove Products Co., Ltd Latex Examination Gloves
104 Moo 1 Banlum, Vihandeang, 11/30/93
Saraburi, Thailand
MID# THTKGLO104SAR
MID# THTKGLO104VIH
UNITED KINGDOM
Johnson & Johnson MED Limited Disposable Examination
Coronation Road Gloves
Ascot, Berkshire Brand Name "Surgikos
U.K. SL5 9EY Dispos-A-Gloves"
4/16/93
ATTACHMENT B 7/25/01
***Note: A Warning Letter has been issued to the following firm(s) citing
adulteration within the meaning of Section 501(h) of the Federal Food, Drug
and Cosmetic Act as documented by recurring violations. Future glove
shipments are subject to refusal of admission pursuant to Section
801(a)(1). Non-violative analyses may not be sufficient to remove the
appearance of a violation for manufacturers/shippers on Attachment B, as
stated under Level 3 Detention.
Indonesia
*** PT. Eka Wira Asia Nitrile Examination Gloves
Jl. Haji Zainal Arifin 128 B-C (Powder Free) 80LZC
Medan 20112, Indonesia Latex Exam Gloves - 80LYY, 80FMC,
FEI# 3002512629 80LZA, 80LZC, 80LYZ - 3/10/99
Correction to FEI #
(Old Corporate Office)
7/25/01
*** PT. Eka Wira Asia (Current Corporate Office)
J1. Prof. HM SH No: 40-40A 7/25/01
Medan 20234 - Indonesia
FEI# 3002343185
*** PT. Eka Wira Asia (Current Manufacturing Facility)
J1. Raya Medan Namorabe Ps. IV 7/25/01
Kabupaten Deli Serdang
Indonesia
FEI# 1000435248
Malaysia
*** DASH MEDICAL GLOVES SDN. BHD. PATIENT EXAMINATION GLOVES
LOT 16 LENGKONGAN HISHAMUDDIN
KAW 20, SELAT KLANG UTARA PC-80LYY, 80FMC, 80LZA, 80LZC
4200 PELABUHAN KLANG 80LYZ - 9/7/99
SELANGOR DARUL ESHAN, MALAYSIA
FEI# 1000359083
*** Evergrade Healthcare Products Powder-Free Latex Examination
Sdn. Bhd. Gloves/80LYY
lot 2783. 73/4 Miles, Jalan Bakri 12/21/99
84200 Muar Johor
Malaysia
FEI# 1000169589
*** Glovesworld Industries Inc. Examination Gloves
(formerly Perusahaan Intan Emas Sdn Bhd) 80LYY, 80FMC, 80LYZ, 80LZA,
Lot P.T. 153 80LZC
Kawasan Perusahaan Beranang 8/1/00
Darul Ehsan
Selangor, Malaysia 56100
FEI# 3168 and 3002618198
(OFFICE) 6TH Floor, Wisma Chinese Chamber
258 Jalan Ampang
50450 Kuala Lumpur, Malaysia
FEI# 3002618198
*** PWA Industries Sdn. Bhd. Patient Examination
BATU 15 1/2 Sungai Pelong Gloves
47000 Sungai Bulch 80LYY, 80FMC,80LZA,80LZC
Selangor Darul Ehsan, Malaysia 5/7/99
FEI# 3000232672
*** S.J. Medical Products Latex Examination Gloves
(M) SDN. BHD. Product Code 80LYY, 80LYZ, 80LZA,
Lot 723 Batu 5 1/2 80LZC, 80FMC, Powder Free
Jalan Kapar 2/25/99
42100 Klang Malaysia
FEI#: 1000258938
*** Tower Rubber Industries Latex Examination Gloves
SDN BHD (Powdered)
Lot 18, Jalan Lingkaran Product Code: 80LYY
Sultan Hishamuddin 1/5/00
Kawasan Perusahaan Selat
Kelang Utara, 42000 Pelabuhan
Kelang, Selangor Darul Ehsan
Malaysia
FEI#: 3091
TAIWAN (TW)
*** Hiyi Export Company Patient Examination Gloves
5F-13, No. 1, Lane 126 80LYY
Fu-Hsing S. Road Sec. 1 80LZA
Taipei, Taiwan 80LZC
FEI# 3001631817 80LYZ
80FMC
4/17/01