ASTM D7866-14

Standard Specification For Radiation Attenuating Protective Gloves

D7866-14

Standard Organization: ASTM

ASTM D7866-14
Standard Specification for Radiation Attenuating Protective Gloves

Recognition NumberGeneral Plastic Surgery/General Hospital
Recognition Date2019-01-14
Recognition List051
Recognition Number6-338
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

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

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.

Code of Federal Regulations:

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

FDA Guidance:

Medical Glove Guidance Manual - Guidance for Industry and FDA Staff, Issued January 2008.


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