ASTM_D_6319_-_19.pdf

Designation:D631919Standard Specification forNitrile Examination Gloves for Medical Application1This standard is issued under the fixed designation D6319;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers certain requirements for nitrilerubber gloves used in conducting medical examinations anddiagnostic and therapeutic procedures.1.2 This specification covers nitrile rubber examinationgloves that fit either hand,paired gloves,and gloves by size.Italso provides for packaged sterile or nonsterile or bulk non-sterile nitrile rubber examination gloves.1.3 This specification is similar to that of SpecificationD3578 for rubber examination gloves.1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.5 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD573 Test Method for RubberDeterioration in an AirOvenD3578 Specification for Rubber Examination GlovesD3767 Practice for RubberMeasurement of DimensionsD5151 Test Method for Detection of Holes in MedicalGlovesD6124 Test Method for Residual Powder on Medical Gloves2.2 ISO Standard:ISO 2859 Sampling Procedures and Tables for Inspection byAttributes32.3 Other Documents:U.S.Pharmacopeia43.Significance and Use3.1 The specification is intended as a referee procedure forevaluating the performance and safety of nitrile rubber exami-nation gloves.The safe and proper use of nitrile rubberexamination gloves is beyond the scope of this specification.4.Material4.1 Any nitrile rubber polymer compound may be used thatpermits the glove to meet the requirements of this specification.4.2 A lubricant that meets the current requirements of theU.S.Pharmacopeia for absorbable dusting powder may beapplied to the glove.Other lubricants may be used if theirsafety and efficacy have been previously established.4.3 The inside and outside surface of the nitrile rubberexamination gloves shall be free of talc.5.Sampling5.1 For referee purposes,gloves shall be sampled fromfinished product,after sterilization when labeled sterile,andinspected in accordance with ISO 2859.The inspection levelsand acceptable quality levels(AQL)shall conform to thosespecified in Table 1,or as agreed upon between the purchaserand the seller,if the latter is more comprehensive.6.Performance Requirements6.1 Gloves,sampled in accordance with Section 5,shallmeet the following referee performance requirements:6.1.1 Product comply with requirements for sterility whentested in accordance with 7.2 when labeled sterile.6.1.2 Shall comply with freedom from holes when tested inaccordance with 7.3.6.1.3 Have consistent physical dimensions in accordancewith 7.4.1This specification is under the jurisdiction ofASTM Committee D11 on Rubberand Rubber-like Materials and is the direct responsibility of Subcommittee D11.40on Consumer Rubber Products.Current edition approved Nov.1,2019.Published December 2019.Originallyapproved in 1999.Last previous edition approved in 2015 as D6319 10(2015).DOI:10.1520/D6319-19.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute,25 W.43rd St.,4thFloor,New York,NY 10036.4U.S.Pharmacopeia,latest edition,Mack Publishing Co.,Easton,PA 19175.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.1 6.1.4 Have acceptable physical property characteristics inaccordance with 7.5.6.1.5 Have a powder residue limit of 2.0 mg in accordancewith 7.66.1.6 Have a recommended maximum powder limit of 10mg/dm2in accordance with 7.7.7.Referee Test Methods7.1 The following tests shall be conducted to ensure therequirements of Section 6,as prescribed in Table 1:7.2 Sterility TestTesting for sterility shall be conducted inaccordance with the latest edition of the U.S.Pharmacopeia.7.3 Freedom from HolesTesting for freedom