1、Designation:D710306(Reapproved 2013)Standard 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 parent
2、heses 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 o
3、f 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 he
4、alth-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 avail
5、abletechnical 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 and health practices and determine
6、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 AirOvenD3577 Specification for Rubber Surgical GlovesD3578 Specification for
7、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 Natural Rubber and Its Products
8、 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 Polychlorop
9、rene ExaminationGloves for Medical ApplicationF739 Test Method for Permeation of Liquids and Gasesthrough Protective Clothing Materials under Conditions ofContinuous ContactF1342 Test Method for Protective Clothing Material Resis-tance to PunctureF1383 Test Method for Permeation of Liquids and Gases
10、through Protective Clothing Materials under Conditions ofIntermittent ContactF1671 Test Method for Resistance of Materials Used inProtective Clothing to Penetration by Blood-Borne Patho-gens Using Phi-X174 Bacteriophage Penetration as a TestSystem2.2 American National Standards Institute/American De
11、ntalAssociation(ANSI/ADA)Standards:Acceptance Program Guidelines Infection Control Products3Specification No.76 Non-Sterile Natural Rubber LatexGloves for Dentistry3Specification No.102 Non-Sterile Nitrile Gloves for Den-tistry3Specification No.103 Non-Sterile Poly(vinyl chloride)Gloves for Dentistr
12、y32.3 International Standards Organization(ISO)Standard:ISO 2859 Sampling Procedures and Tables for Inspection byAttributes32.4 National Fire Protection Association(NFPA)Standard:NFPA 1999 Standard on Protective Clothing for EmergencyMedical Operations41This guide is under the jurisdiction of ASTM C
13、ommittee D11 on Rubber andis the direct responsibility of Subcommittee D11.40 on Consumer Rubber Products.Current edition approved May 1,2013.Published May 2013.Originallyapproved in 2006.Last previous edition approved in 2006 as D7103 061.DOI:10.1520/D7103-06R13.2For referenced ASTM standards,visit
14、 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.
15、4Available from National Fire Protection Association(NFPA),1 BatterymarchPark,Quincy,MA 02269-9101.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.Terminology3.1 Definitions:3.1.1 medical glovessurgeons(surgical)and patient ex-amination
16、(examination)gloves for use in medical applica-tions.Medical gloves are medical devices that are regulated byThe Food and Drug Administration(FDA).3.1.2 natural rubber latex(NRL)glovesgloves manufac-tured from natural rubber latex(latex).3.1.3 syntheic plastic glovesgloves manufactured from asynthetic plastic material such as poly(vinyl chloride).3.1.3.1 DiscussionThe actual name of the plastic materialmust be stated on the packaging.3.1.4 synthetic rubber glovesgloves manufactured from asynthet
