Recognized standard
D7866-14
FDA recognition 6-338 · ASTM · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-338 |
|---|---|
| Designation | D7866-14 |
| Title | Standard Specification for Radiation Attenuating Protective Gloves |
| Standards developer | ASTM International |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 1 |
| Scope (excerpt) | 1.1 To describe the requirements for packaged protective gloves with radiation attenuating properties intended to protect the operator or other persons from unnecessary exposure to radiation during radiological procedures by providing an attenuating barrier to radiation. Minimum attenuation values… |
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: