ASTM_D_7103_-_19.pdf

Designation:D710319Standard Guide forAssessment of Medical Gloves1This standard is issued under the fixed designation D7103;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 guide is intended to assist in the identification andapplication of the most appropriate ASTM and associatedstandards for the assessment,development of specifications,and selection of medical gloves with the ultimate goal ofmaintaining the safety and health of healthcare workers whomay come into contact with biological and chemical hazards.1.2 No guidance document or assessment protocol canensure the selection of medical gloves that guarantees health-care worker protection.The purpose of testing and assessingmedical gloves is to generate the performance data and qualityinformation that will allow the most appropriate assessmentand selection of medical gloves.Ultimately,the selection ofmedical gloves shall be based on the evaluation of availabletechnical data,quality information,and professional assess-ment of risk.1.3 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,health,and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.4 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 AirOvenD3577 Specification for Rubber Surgical GlovesD3578 Specification for Rubber Examination GlovesD3767 Practice for RubberMeasurement of DimensionsD5151 Test Method for Detection of Holes in MedicalGlovesD5250 Specification for Poly(vinyl chloride)Gloves forMedical ApplicationD5712 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 GlovesD6319 Specification for Nitrile Examination Gloves forMedical ApplicationD6355 Test Method for Human Repeat Insult Patch Testingof Medical GlovesD6499 Test Method for Immunological Measurement ofAntigenic Protein in Hevea Natural Rubber(HNR)and itsProductsD6977 Specification for Polychloroprene ExaminationGloves for Medical ApplicationD6978 Practice for Assessment of Resistance of MedicalGloves to Permeation by Chemotherapy DrugsD7102 Guide for Determination of Endotoxin on SterileMedical GlovesD7160 Practice for Determination of Expiration Dating forMedical GlovesD7161 Practice for Determination of Real Time ExpirationDating of Mature Medical Gloves Stored Under TypicalWarehouse ConditionsD7198 Specification for Disposable Embalming Gloves forSingle-Use ApplicationsD7427 Test Method for Immunological Measurement ofFour PrincipalAllergenic Proteins(Hev b 1,3,5 and 6.02)in Hevea Natural Rubber and Its Products Derived fromLatexD7558 Test Method for Colorimetric/SpectrophotometricProceduretoQuantifyExtractableChemicalDialkyldithiocarbamate,Thiuram,and Mercaptobenzothi-azole Accelerators in Natural Rubber Latex and NitrileGlovesD7866 Specification for Radiation Attenuating ProtectiveGlovesD7907 Test Methods for Determination of Bactericidal Ef-ficacy on the Surface of Medical Examination Gloves1This guide is under the jurisdiction of ASTM Committee D11 on Rubber andRubber-like Materials and is the direct responsibility of Subcommittee D11.40 onConsumer Rubber Products.Current edition approved Oct.1,2019.Published October 2019.Originallyapproved in 2006.Last previous edition approved in 2018 as D7103 18.DOI:10.1520/D7103-19.2For 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.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 F739 Test Method for Permeation of Liquids and GasesThrough Protective Clothing Materials Under Conditionsof Continuous ContactF1342 Test Method for Protective Clothing Materi