Recognized standard
D3492-16
FDA recognition 9-120 · ASTM · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-120 |
|---|---|
| Designation | D3492-16 |
| Title | Standard Specification for Rubber Contraceptives (Male Condoms) |
| Standards developer | ASTM International |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | This specification covers the minimum requirements for individually packaged male condoms made from natural rubber latex and intended for single use. |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: