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Information for a Latex Condom 510(k) Submission for Obstetrics-Gynecology Devices Branch DRAFT

This guidance was written prior to the February 27, 1997 implementation of FDA’s Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP’s.

The following information should be included for a premarket notification (510(k)) submission for a natural latex rubber condom:

1. Device Description and Material Safety
   1. Identify a legally marketed device, and compare your device to the legally marketed device in terms of intended use, design, materials, specifications and performance. Where applicable, photographs or engineering drawings should be supplied.

   2. Provide the chemical composition of your condom latex formulation, including any additives, e.g., antioxidants, accelerators, etc.

   3. Provide the chemical composition of the dusting agent and the lubricant to be applied.

   4. Provide the chemical composition of the color additive(s) that is used with the condom(s), if applicable. Also, identify the color index number and a reference to the specific color additive listing (21 CFR reference).

   5. Provide biocompatibility data, including mucosal irritation, sensitization, and acute systemic toxicity, on the final product to support its safe use. Protocols, as well as test data and conclusions, from the toxicological testing of the finished condom must be provided. (Please refer to FDA's Tripartite Biocompatibility for Medical Devices Guidance for selecting the appropriate types of tests; TAB 1)

   6. Provide a description of the manufacturing processes instituted to minimize any potential adverse effects of latex hypersensitivity (Please refer to FDA's Safety Alert; TAB 2)

2. Quality Assurance
   1. Provide a detailed description of the air burst test procedure and identify the acceptable quality level (AQL) used by the manufacturer to establish the quality of each condom lot or batch. FDA requires that final product release testing include the International Organization for Standardization (ISO 4074-1:1990(E)) Rubber Condoms - Part 6: Determination of Bursting Volume and Pressure (ISO 4074-6:1984). (Please refer to TAB 3)

   2. Provide a detailed description of the water leakage test procedure and its acceptable quality level (AQL) used by the manufacturer to establish the quality of each condom lot or batch. FDA requires that final product release testing includes water leakage testing per American Society for Testing and Materials, Standard Specification for Rubber Contraceptives (Condoms) (ASTM D 3492-89). (Please refer to TAB 3)

   3. Provide a detailed description of all other in-process and final release test procedures, e.g., tensile strength, elongation, color fastness, packaging integrity, etc., and identify their acceptable quality level (AQL). Also, identify when quality control tests are conducted during the manufacturing process.

   4. Provide a detailed description of the electronic testing procedures, including a description of the electronic testing machine, the machines' specifications, operators manual, and a description of the electronic testing machines' calibration procedures. Also, describe any relationship between the electronic testing machines' calibration procedures and results of physical testing procedures used for product release.

3. Labeling

   Provide copies of labels, labeling and advertisements sufficient to describe the device:

   1. the intended use and directions for use (Please refer to FDA's April 7 and July 31, 1987 and February 13, 1989 letters - TAB 4);

   2. a statement that only water based lubricants be used with latex condoms;

   3. the statement, "If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases." This statement should be located on both sides of each individual condom package, on the principal display panel of the outer box and also be included on any package insert. (Please refer to April 8, 1993, letter to condom manufacturers - TAB 5);

   4. the nominal width;

   5. the date of manufacture or an acceptable expiration date; and

   6. a statement of specific contraceptive effectiveness cautionary provision for condoms with spermicidal lubricant. (Please refer to TAB 6)

4. Shelf Life

   Identify if your device labeling includes a proposed shelf life. If applicable specify the proposed shelf life and provide data to support the proposed shelf life. (Please refer to TAB 7.)

5. Safe Medical Device Act (SMDA) Requirement

   The Safe Medical Device Act (SMDA) requires all persons submitting a premarket notification submission to include either (1) a statement that you will make available to interested persons upon request, the safety and effectiveness information in this premarket notification that is relevant to an assessment of substantial equivalence or (2) a summary of the safety and effectiveness information in the premarket notification submission upon which an equivalence determination is based. Safety and effectiveness information refers to information in the premarket notification submission, including adverse safety and effectiveness information that supports a finding of substantial equivalence. The information could be descriptive information about the new and predicate device, or performance or clinical testing information.

To:	CDRH Document Coordinator HHS/PHS/FDA/CDRH/OTA/DSMA 5600 Fishers Lane, HFZ-229 Rockville, MD 20857 United States
To Fax:	301.443.8818	Date: ___/___/___

This page is to request the Tabs referenced in the text of INFORMATION FOR A LATEX CONDOM 510(k) SUBMISSION FOR OBSTETRICS-GYNECOLOGY DEVICES BRANCH that are not available as DOS text.

1] Check the item(s) desired,
2] fill out the requester information including a voice telephone number, and
3] fax or mail the request as indicated above.

[    ]	Tab 1 General Program Memorandum - #G95-1 Draft Immunotoxicity Testing Framework
[    ]	Tab 2 FDA Medical Alert "Allergic Reactions to Latex-Containing Medical Devices
[    ]	Tab 3 Memo to Condom Manufactures and Distributors Standard Specification for Rubber Contraceptives (Condoms)
[    ]	Tab 4 Memos to All U.S. Condom Manufacturers, Importers and Repackagers
[    ]	Tab 5 Memo to Latex Condom Manufacturers
[    ]	Tab 6 Information for Condoms with a Spermicidal Lubricant 510(k) Submission for Obstetrics-Gynecology Devices Branch
[    ]	Tab 7 Expiration Date of Condoms

Requester Information
Name:	_______________________________________
Company (or N/A for not applicable):	_______________________________________
Mailing address:	_______________________________________
City, State Zip Code:	_______________________________________
Voice telephone:	_____._____.________
Email address:	___________________

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