ASTM D6977-04 (Reapproved 2016)

Standard Organization:

ASTM D6977-04 (Reapproved 2016)
Standard Specification for Polychloroprene Examination Gloves for Medical Application

• Recognition Date: 2016-12-23
• Recognition List: 046
• Recognition Number: 6-165
• Extent: Complete standard
• Standards Orgs: ASTM ASTM International http://www.astm.org/
• STG: General Plastic Surgery/General Hospital
• FDA Tech: Katharine Segars FDA/OMPT/CDRH/ODE/DAGID/INCB 240-402-2780 Katharine.Segars@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 This specification provides certain requirements for polychloroprene rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures.

1.2 This specification covers polychloroprene rubber examination gloves that fit either hand, paired gloves, and gloves by . It also provides for packaged sterile or non-sterile or bulk non-sterile polychloroprene rubber examination gloves.

1.3 This specification is similar to that of D3578 Standard Specification for Rubber Examination Gloves, and D6319 Standard Specification for Nitrile Examination Gloves for Medical Applications.

Code of Federal Regulations:

Regulation Number	Device Name	Device Class	Product Code
§880.6250	Polymer Patient Examination Glove	Class 1	LZA

FDA Guidance:

Guidance for Industry and FDA Staff - Medical Glove Guidance Manual, Issued January 22, 2008.

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 2, 2014.