ASTM_D_3577_-_09_2015.pdf

Designation:D357709(Reapproved 2015)Standard Specification forRubber Surgical Gloves1This standard is issued under the fixed designation D3577;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 pack-aged sterile rubber surgical gloves used in conducting surgicalprocedures.1.2 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.3 The following safety hazards caveat pertains only to thetest method portion,Section 8,of this specification:Thisstandard does not purport to address all of the safety concerns,if any,associated with its use.It is the responsibility of the userof this standard to establish appropriate safety and healthpractices and determine the applicability of regulatory limita-tions prior to use.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 1Gloves compounded primarily from naturalrubber latex.3.2 Type 2Gloves compounded from a rubber cement orfrom synthetic rubber latex.4.Materials and Manufacture4.1 Any rubber polymer 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 rubber surgicalgloves shall be free of talc.5.Significance and Use5.1 The specification is intended as a reference to theperformance and safety of rubber surgical gloves.The safe andproper use of rubber surgical gloves is beyond the scope of thisspecification.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: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 2009 as D3577 091.DOI:10.1520/D3577-09R15.2For 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 West 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 States1 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 8.6.7.1.6 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 15mg/dm2in accordance with 8.8.8.Referee Test Methods8.1 The following tests shall be conducted to assure therequirements of Section 7 as prescribed in Table 1:8.2 Sterility Test Testing 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:8.4.1 The gloves shall comply with the dimension require-men