| ISO 25841 Third edition 2017-08 Female condoms -- Requirements and test methods |
| Recognition Number | ObGyn/Gastroenterology/Urology |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 9-122 |
| 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 document specifies the minimum requirements and test methods for female condoms that are supplied to consumers for contraceptive purposes and for assisting in the prevention of sexually transmitted infections (STIs).
| Regulation Number | Device Name | Device Class | Product Code |
| §884.5340 | Single-Use Internal Condom | Class 2 | MBU |
| Premarket Testing Guidelines for Female Barrier Contraceptive Devices Also Intended to Prevent Sexually Transmitted Diseases, Issued on April 1990. Guidance for Industry: User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide, Issued April 2003. |