| ISO 4074 Third edition 2015-10-15 Natural latex rubber condoms - Requirements and test methods |
| Recognition Number | ObGyn/Gastroenterology/Urology |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 9-111 |
| 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.
ISO 4074:2015 specifies requirements and test methods for male condoms made from natural rubber latex.
| 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. |