# Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex
> **Food and Drug Administration** · Final rule. · Published 2008-11-10 · Effective 2009-01-09 · 73 FR 66522
## Document
- **Document number:** E8-26825
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 73 FR 66522
- **CFR reference:** 21 CFR 884
- **Publication date:** 2008-11-10
- **Effective date:** 2009-01-09
- **HHS docket:** Docket No. FDA-2004-N-0511
## Abstract

The Food and Drug Administration (FDA) is amending the classification regulation for condoms to designate a special control for male condoms made of natural rubber latex (latex). The special control for the device is the guidance document entitled "Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300." The FDA will publish a notice in the Federal Register announcing the availability of the special control guidance document no later than the effective date of this final rule.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2008/11/10/E8-26825/obstetrical-and-gynecological-devices-designation-of-special-controls-for-male-condoms-made-of)
---
*AI Analytics · CC0 1.0*