ASTM_D_7198_-_05_2012.pdf

Designation:D719805(Reapproved 2012)Standard Specification forDisposable Embalming Gloves for Single-Use Applications1This standard is issued under the fixed designation D7198;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 natu-ral rubber(Latex),synthetic rubber(Polychloroprene andNitrile),and vinyl(PVC)disposable gloves for use in conduct-ing single-use embalming procedures.1.2 This specification covers natural rubber(Latex),syn-thetic rubber(Polychloroprene and Nitrile),and Vinyl(PVC)disposable gloves that fit either hand,paired gloves,gloves bysize,and gloves packed in bulk.1.3 An assessment to measure the chemical resistanceperformance of the glove can be made based on the ultimatepermeation(breakthrough)of embalming chemicals throughthe glove material over a specified period of time.1.4 This specification is similar to the following specifica-tions:D3578,D4679,D5250,D6319,and D6977.1.5 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.6 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations 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 AirOvenD3578 Specification for Rubber Examination GlovesD3767 Practice for RubberMeasurement of DimensionsD4679 Specification for Rubber General Purpose,House-hold or Beautician GlovesD5151 Test Method for Detection of Holes in MedicalGlovesD5250 Specification for Poly(vinyl chloride)Gloves forMedical ApplicationD5712 Test Method for Analysis of Aqueous ExtractableProtein in Natural Rubber and Its Products Using theModified Lowry MethodD6124 Test Method for Residual Powder on Medical GlovesD6319 Specification for Nitrile Examination Gloves forMedical ApplicationD6499 Test Method for The Immunological Measurement ofAntigenic Protein in Natural Rubber and its ProductsD6977 Specification for Polychloroprene ExaminationGloves for Medical ApplicationF739 Test Method for Permeation of Liquids and Gasesthrough Protective Clothing Materials under Conditions ofContinuous Contact2.2 ISO Standard:ISO 2859 Sampling Procedures and Tables for Inspection byAttributes32.3 Other Document:U.S.Pharmacopeia43.Significance and Use3.1 This specification is intended to be a specification forevaluating the performance and quality of disposable naturalrubber,synthetic rubber,and vinyl(PVC)gloves for single-useembalming applications.3.2 The safe and proper use of disposable natural rubber,synthetic rubber(polychloroprene and nitrile),and vinyl glovesis beyond the scope of this specification.3.3 The chemical permeation tests described in this speci-fication are intended to be“Type Tests”for these types ofgloves.3.3.1 The chemical permeation tests are not intended to betesting instructions nor testing protocols to be used for routinelot release.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 Dec.1,2012.Published February 2013.Originallyapproved in 2005.Last previous edition approved in 2005 as D7198 05.DOI:10.1520/D7198-05R12.2For 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 4.Materials and Manufacture4.1 Any natural rubber,synthetic rubber,and plastic poly-mer compound may be used that permits the glove to meet therequirements of this specification.4.2 A lubricant that meets the current requirements of theU.S.Pharmacopoeia 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 rubber,synthetic rubber,and plastic disposable gloves shall be free oftalc.5.Sampling5.1 For referee purposes,gloves shall be sampled fromfinished product and inspected in accordance with ISO 2859.The inspection levels and acceptable quality levels(AQL)shallconform to those specified in Ta