Recognized standard
D7661-18
FDA recognition 9-145 · ASTM · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-145 |
|---|---|
| Designation | D7661-18 |
| Title | Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms |
| Standards developer | ASTM International |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | May 29, 2023 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This test method covers procedures used to detect a shift in physical properties of natural rubber latex (NRL) condoms after immersion in a personal lubricant. "Personal lubricants" are lubricants such as liquids or gels that are applied by the consumer at the time of condom use. 1.2 This test… |
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: