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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Recognition 01/14/2019 
FR Recognition Number 6-338
Standard
ASTM D7866-14
Standard Specification for Radiation Attenuating Protective Gloves
Scope/Abstract
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.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)
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
Relevant FDA Guidance and/or Supportive Publications
Medical Glove Guidance Manual - Guidance for Industry and FDA Staff, Issued January 2008.
FDA Technical Contact
 John Stansberry
  FDA/OMPT/CDRH/ODE/DAGID/INCB
  240-402-8915
  John.Stansberry@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
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