Recognized standard
D5151-19(2023)
FDA recognition 6-424 · ASTM · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-424 |
|---|---|
| Designation | D5151-19(2023) |
| Title | Standard Test Method for Detection of Holes in Medical Gloves |
| Standards developer | ASTM International |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Dec 23, 2019 |
| Device classes | Class 1 |
| Scope (excerpt) | 1.1 This test method covers the detection of holes in medical gloves. 1.2 This test method is limited to the detection of holes that allow water leakage under the conditions of the test. 1.3 The smallest hole that will allow water leakage in a medical glove has not been determined and is beyond the… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
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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: