ASTM_D_3578_-_05_2015.pdf

Designation:D357805(Reapproved 2015)Standard Specification forRubber Examination Gloves1This standard is issued under the fixed designation D3578;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.This standard has been approved for use by agencies of the U.S.Department of Defense.1.Scope1.1 This specification covers certain requirements for natu-ral rubber gloves used in conducting medical examinations anddiagnostic and therapeutic procedures.It also covers naturalrubber gloves used in handling contaminated medical material.1.2 This specification provides for natural rubber gloves thatfit either hand,paired gloves,and gloves by size.It alsoprovides for packaged sterile natural rubber gloves and pack-aged or bulk nonsterile natural rubber gloves.2.Referenced Documents2.1 ASTM Standards:2D412 Test Methods for Vulcanized Rubber and Thermoplas-tic ElastomersTensionD573 Test Method for RubberDeterioration in an AirOvenD3767 Practice for RubberMeasurement of DimensionsD5151 Test Method for Detection of Holes in MedicalGlovesD5712 Test Method for Analysis of Aqueous ExtractableProtein in Latex,Natural Rubber,and Elastomeric Prod-ucts Using the Modified Lowry MethodD6124 Test Method for Residual Powder on Medical GlovesD6499 Test Method for The Immunological Measurement ofAntigenic Protein in Natural Rubber and its Products2.2 Other Documents:ISO 2859 Sampling Procedures and Tables for Inspection byAttributes3U.S.Pharmacopeia43.Classification3.1 Type IGloves with a minimum tensile strength of 18MPa and a maximum stress at 500%elongation of 5.5 MPa.3.2 Type IIGloves with a minimum tensile strength of 14MPa and a maximum stress at 500%elongation of 2.8 MPa.4.Materials and Manufacture4.1 Any natural rubber compound that permits the glove tomeet 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 natural rubberexamination gloves shall be free of talc.5.Significance and Use5.1 The specification is intended as a reference to theperformance and safety of natural rubber examination gloves.The safe and proper use of natural rubber examination glovesis beyond the scope of this specification.6.Sampling6.1 For referee purposes,gloves shall be sampled andinspected in accordance with ISO 2859.The inspection levelsand acceptable quality levels(AQL)shall conform to thosespecified in Table 1,or as agreed between the purchaser and theseller,if the latter is more comprehensive.7.Performance Requirements7.1 Gloves,sampled in accordance with Section 6,shallmeet the following referee performance requirements:7.1.1 Comply with requirements for sterility when tested inaccordance with 8.2.7.1.2 Be free from holes when tested in accordance with 8.3.7.1.3 Have consistent physical dimensions in accordancewith 8.4.7.1.4 Have acceptable physical property characteristics inaccordance with 8.5.7.1.5 Have a powder residue limit of 2.0 mg in accordancewith 8.6.1This specification is under the jurisdiction ofASTM Committee D11 on Rubberand is the direct responsibility of Subcommittee D11.40 on Consumer RubberProducts.Current edition approved Nov.1,2015.Published December 2015.Originallyapproved in 1977.Last previous edition approved in 2010 as D3578 05(2010).DOI:10.1520/D3578-05R15.2For 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(ANSI),25 W.43rd St.,4th Floor,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 States1 7.1.6 Have a recommended aqueous soluble protein contentlimit of 200 g/dm2in accordance with 8.7 and Annex A1 orhave a recommended antigenic protein content limit of 10g/dm2in accordance with 8.9 and Annex A2.7.1.7 Have a recommended maximum powder limit of 10mg/dm2in accordance with 8.8.8.Referee Test Methods8.1 The following tests shall be conducted to ensure therequirements of Section 8,as prescribed in Table 1:8.2 Sterility TestTesting for sterility shall be conducted inaccordance with the latest edition of The U.S.Pharmacopeia.8.3 Freedom From HolesTesting for freedom from holesshall be conducted in accordance with Test Method D5151.8.4 Physical Dimensions Test(Practice D3767):8.4.1 The gloves shall comply with the dimension require-ments prescribed in Table 2.8.4.2 The length