ASTM D6319-10 (Reapproved 2015)

Standard Organization:

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

• Recognition Date: 2016-06-27
• Recognition List: 043
• Recognition Number: 6-244
• 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