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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 049 Date of Recognition 06/07/2018 
FR Recognition Number 6-178
Standard
ASTM D6124-06 (Reapproved 2017)
Standard Test Method for Residual Powder on Medical Gloves
Scope/Abstract
1.1 This test method covers the determination of average powder or filter-retained mass found on a sample of medical gloves as described in the introduction.

1.2 The average powder mass per glove is reported in milligrams.

1.3 The safe and proper use of medical gloves is beyond the scope of this test method.

1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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
§880.6250 Polymer Patient Examination Glove Class 1 LZA
§880.6250 Vinyl Patient Examination Glove Class 1 LYZ
§878.4460 Surgeon'S Gloves Class 1 KGO
Relevant FDA Guidance and/or Supportive Publications
Guidance for Industry and FDA - Medical Glove Guidance Manual. Issued January 2008.
FDA Technical Contact
 Katharine Segars
  FDA/OMPT/CDRH/ODE/DAGID/INCB
  240-402-2780
  Katharine.Segars@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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