ASTM_D_6124_-_06_2022.pdf

Designation:D612406(Reapproved 2022)Standard Test Method forResidual Powder on Medical Gloves1This standard is issued under the fixed designation D6124;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.INTRODUCTIONThis standard is designed to determine the amount of residual powder(or filter-retained mass)foundon medical gloves.This standard consists of two test methodologies.Procedure I is a method for thequantification of residual powder on gloves described as non-powdered,powder-free,powderless,nopowder,or other words to that effect.Procedure II is a test method for the quantitation of powder(andother filter-retained mass)on powdered gloves.1.Scope1.1 This test method covers the determination of averagepowder or filter-retained mass found on a sample of medicalgloves as described in the introduction.1.2 The average powder mass per glove is reported inmilligrams.1.3 The safe and proper use of medical gloves is beyond thescope of this test method.1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.5 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.1.6 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:2D4483 Practice for Evaluating Precision for Test MethodStandards in the Rubber and Carbon Black ManufacturingIndustries2.2 Other Documents:American National Standard ANSI/ASQC Z1.91993 Sam-pling Procedures and Tables for Inspection by Variablesfor Percent Nonconforming33.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 medical glovesas used in this test method,refer toboth surgical and examination gloves.3.1.2 powderany water insoluble,filter-retained residueremaining on the glove after the manufacturing process.3.1.3 powder-freeis also referred to as powderless,nopowder,non-powdered,or words to that effect.4.Significance and Use4.1 This test method is designed to determine the amount ofresidual powder and non-powder solids found on medicalgloves.4.2 This test method is suitable and designed as a referencemethod to evaluate samples of medical gloves.4.3 The mass found using Procedure II,for powderedgloves,is assumed to be a combination of water-insolubleresidue remaining after the manufacturing process,formerrelease agents and donning powder.5.Apparatus5.1 Analytical Balance capable of readability and repeat-ability to 0.1 mg.1This test method is under the jurisdiction of Committee D11 on Rubber andRubber-like Materials and is the direct responsibility of Subcommittee D11.40 onConsumer Rubber Products.Current edition approved June 1,2022.Published July 2022.Originally approvedin 2000.Last previous edition approved in 2017 as D6124 06(2017).DOI:10.1520/D6124-06R22.2For 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 W.43rd St.,4thFloor,New York,NY 10036.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.15.2 Reciprocal or Rotator Mechanical Shaker capable of aminimum speed of 1.7 Hz(100 cycles/min).5.3 Gravimetric convection oven.6.Procedure I,for Quantitation of Powder on Powder-free Gloves6.1 Powder Test,Powder-Free GlovesTotal Glove:6.1.1 Prior to use,all glassware and tweezers shall be rinsedwith deionized or distilled water.6.2 Filter Preparation:6.2.1 Use a 47 mm,2.7 m pore size glass microfiber filterand a suction filtration apparatus.Use of a TFE-fluorocarbon orequivalent-rimmed housing base is recommended if filtersadhere or tear upon removal from glass-rimmed surface.6.2.2 Insert the filter disk in the filtration apparatus.Applysuction and wash the filter disk with three successive 50 mLportions of deionized or distilled water.Continue