ASTM D6319-10 (Reapproved 2015)

Standard Organization:

ASTM D6319-10 (Reapproved 2015)
Standard Specification for Nitrile Examination Gloves for Medical Application

Recognition Date2016-06-27
Recognition List043
Recognition Number6-244
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 This specification covers certain requirements for nitrile rubber gloves used in conducting medical examinations and diagnostic and therapeutic procedures.

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

1.3 This specification is similar to that of Specification D3578 for rubber examination gloves.

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


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