Recognized standard
4074 Third edition 2015-10-15
FDA recognition 9-111 · ISO · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-111 |
|---|---|
| Designation | 4074 Third edition 2015-10-15 |
| Title | Natural latex rubber condoms - Requirements and test methods |
| Standards developer | International Organization for Standardization |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 4074:2015 specifies requirements and test methods for male condoms made from natural rubber latex. |
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: