| ASTM D3492-16 Standard Specification for Rubber Contraceptives (Male Condoms) |
| Recognition Number | ObGyn/Gastroenterology/Urology |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 9-112 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | ObGyn/Gastroenterology/Urology |
| FDA Tech | Sharon Andrews FDA/OMPT/CDRH/ODE/DRGUD/OGDB/ 301-796-6529 sharon.andrews@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
1.1 This specification covers the minimum requirements for individually packaged male condoms made from natural rubber latex and intended for single use. This specification does not cover the specifications for lubricants or other dressing materials that may be applied to condoms except as noted in 3.2.
1.2 This specification is intended to assist buyers in obtaining condoms of consistent quality. The safe and proper use of condoms is excluded from the scope of this specification.
| Regulation Number | Device Name | Device Class | Product Code |
| §884.5310 | Condom With Nonoxynol-9 | Class 2 | LTZ |
| §884.5300 | Condom | Class 2 | HIS |
| 21 CFR 801.435, User labeling for latex condoms | |||
| Latex Condoms for Men: Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions, Issued July 1998. Guidance for Industry and FDA Staff: Surveillance and Detention without Physical Examination of Condoms, Issued July 2008. Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300, Issued December 2008. Guidance for Industry: Designation of Special Controls for Male Condoms Made of Natural Rubber Latex (21 CFR 884.5300); Small Entity Compliance Guide, Issued January 2009. Guidance for Industry: User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide, Issued April 2003. |