| ISO 23409 First edition 2011-02-15 Male Condoms - Requirements and test methods for condoms made from synthetic materials |
| Recognition Number | ObGyn/Gastroenterology/Urology |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 9-68 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.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.
This International Standard specifies the minimum requirements and the test methods applicable to male condoms produced from synthetic materials or blends of synthetic materials and natural rubber latex which are used for contraceptive purposes and to aid in the prevention of sexually transmitted infections.
| Regulation Number | Device Name | Device Class | Product Code |
| §884.5300 | Condom, Synthetic | Class 2 | MOL |
| Guidance for Industry and FDA Staff: Surveillance and Detention without Physical Examination of Condoms, Issued July 2008. |