Recognized standard
D6355-07(2022)
FDA recognition 6-214 · ASTM · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-214 |
|---|---|
| Designation | D6355-07(2022) |
| Title | Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves |
| Standards developer | ASTM International |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Jun 7, 2018 |
| Device classes | Class 1, Class 2 |
| Scope (excerpt) | 1.1 This test method is designed to evaluate the potential of glove materials under test to induce and elicit Type IV skin sensitization reactions (that is, allergic contact dermatitis) in humans. 1.2 This test method should be used by individuals experienced in or under the supervision of those… |
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: