| ASTM D7866-14 Standard Specification for Radiation Attenuating Protective Gloves |
| Recognition Number | General Plastic Surgery/General Hospital |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 6-338 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | John Stansberry FDA/OMPT/CDRH/ODE/DAGID/INCB 240-402-8915 John.Stansberry@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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 will be defined.
| Regulation Number | Device Name | Device Class | Product Code |
| §892.6500 | Radiographic Protective Glove | Class 1 | IWP |
| §880.6250 | Latex Patient Examination Glove | Class 1 | LYY |
| §880.6250 | Polymer Patient Examination Glove | Class 1 | LZA |
| §878.4460 | Surgeon'S Gloves | Class 1 | KGO |
| Medical Glove Guidance Manual - Guidance for Industry and FDA Staff, Issued January 2008. |