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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 053 Date of Entry 12/23/2019 
FR Recognition Number 6-424
Standard
ASTM  D5151-19(2023)
Standard Test Method for Detection of Holes in Medical Gloves
Scope/Abstract
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 scope of this test method.
1.4 The safe and proper use of medical gloves is beyond the scope of this test method.
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
§878.4460 Surgeon'S Gloves Class 1 KGO
§880.6250 Vinyl Patient Examination Glove Class 1 LYZ
§880.6250 Polymer Patient Examination Glove Class 1 LZA
Relevant FDA Guidance and/or Supportive Publications*
Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex: Guidance for Industry and Food and Drug Administration Staff, Issued December 2014.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Allan Guan
  FDA/CDRH/OPEQ/OHTIV/DHTIVB/
  301-796-2851
  Allan.Guan@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.
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