2024年5月6日发(作者：郭明珠)
Designation:D3577–09
StandardSpecificationfor
RubberSurgicalGloves
1
ThisstandardisissuedunderthefixeddesignationD3577;thenumberimmediatelyfollowingthedesignationindicatestheyearof
originaladoptionor,inthecaseofrevision,rinparenthesesindicatestheyearoflastreapproval.A
superscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.
ThisstandardhasbeenapprovedforusebyagenciesoftheDepartmentofDefense.
1.1Thisspecificationcoverscertainrequirementsforpack-
agedsterilerubbersurgicalglovesusedinconductingsurgical
procedures.
1.2ThevaluesstatedinSIunitsaretoberegardedas
runitsofmeasurementareincludedinthis
standard.
1.3Thefollowingsafetyhazardscaveatpertainsonlytothe
testmethodportion,Section8,ofthisspecification:This
standarddoesnotpurporttoaddressallofthesafetyconcerns,
ifany,eresponsibilityoftheuser
ofthisstandardtoestablishappropriatesafetyandhealth
practicesanddeterminetheapplicabilityofregulatorylimita-
tionspriortouse.
ncedDocuments
2.1ASTMStandards:
2
D412TestMethodsforVulcanizedRubberandThermo-
plasticElastomers—Tension
D573TestMethodforRubber—DeteriorationinanAir
Oven
D3767PracticeforRubber—MeasurementofDimensions
D5151TestMethodforDetectionofHolesinMedical
Gloves
D5712TestMethodforAnalysisofAqueousExtractable
ProteininNaturalRubberandItsProductsUsingthe
ModifiedLowryMethod
D6124TestMethodforResidualPowderonMedical
Gloves
D6499TestMethodforTheImmunologicalMeasurement
ofAntigenicProteininNaturalRubberanditsProducts
2.2Other
Documents:
--```,,,`,``,,`,,``````````,,,`-`-`,,`,,`,`,,`---
ISO2859SamplingProceduresandTablesforInspection
by
Attributes
3
copeia
4
fication
3.1Type1—Glovescompoundedprimarilyfromnatural
rubberlatex.
3.2Type2—Glovescompoundedfromarubbercementor
fromsyntheticrubberlatex.
alsandManufacture
4.1Anyrubberpolymercompoundthatpermitsthegloveto
meettherequirementsofthisspecification.
4.2Alubricantthatmeetsthecurrentrequirementsofthe
copeiaforAbsorbableDustingPowdermaybe
applied
ubricantsmaybeusediftheir
safetyandefficacyhavebeenpreviouslyestablished.
4.3Theinsideandoutsidesurfaceoftherubbersurgical
glovesshallbefreeoftalc.
ficanceandUse
5.1Thespecificationisintendedasareferencetothe
eand
properuseofrubbersurgicalglovesisbeyondthescopeofthis
specification.
ng
6.1Forrefereepurposes,glovesshallbesampledand
pectionlevels
and
acceptablequalitylevels(AQL)shallconformtothose
specifiedinTable1,orasagreedbetweenthepurchaserandthe
seller,ifthelatterismorecomprehensive.
manceRequirements
7.1Gloves,sampledinaccordancewithSection6,shall
meetthefollowingrefereeperformancerequirements:
7.1.1Complywithrequirementsforsterilitywhentestedin
accordancewith8.2.
AvailablefromAmericanNationalStandardsInstitute,25West43rdSt.,4th
Floor,NewYork,NY10036.
4
copeia,latestedition,MackPublishingCo.,Easton,PA19175.
3
ThisspecificationisunderthejurisdictionofASTMCommitteeD11onRubber
andisthedirectresponsibilityofSubcommitteeD11.40onConsumerRubber
Products.
CurrenteditionapprovedJan.1,ally
eviouseditionapprovedin2006asD3577–06.
2
ForreferencedASTMstandards,visittheASTMwebsite,,or
contactASTMCustomerServiceatservice@ualBookofASTM
Standardsvolumeinformation,refertothestandard’sDocumentSummarypageon
theASTMwebsite.
1
Copyright©ASTMInternational,100BarrHarborDrive,POBoxC700,WestConshohocken,PA19428-2959,UnitedStates.
1
D3577–09
TABLE1PerformanceRequirements
Characteristic
Sterility
Freedomfromholes
Physicaldimensions
Physicalproperties
PowderFreeResidue
ProteinContent
PowderAmount
AntigenicProtein
Content
A
RelatedDefects
failssterility
holes
length,width,and
thickness
beforeaging,afteraccel-
eratedaging
ExceedsMaximumLimit
ExceedsRecommended
MaximumLimit
ExceedsRecommended
MaximumLimit
ExceedsRecommended
MaximumLimit
Inspection
Level
A
AQL
N/A
1.5
4.0
4.0
N/A
N/A
N/A
N/A
I
S-2
S-2
N=5
N=3
N=2
N=1
copeia.
7.1.2Befreefromholeswhentestedinaccordancewith8.3.
7.1.3Haveconsistentphysicaldimensionsinaccordance
with8.4.
7.1.4Haveacceptablephysicalpropertycharacteristicsin
accordancewith8.5.
7.1.5Haveapowderresiduelimitof2.0mginaccordance
with8.6.
7.1.6Havearecommendedaqueoussolubleproteincontent
limitof200µg/dm
2
inaccordancewith8.7andAnnexA1or
havearecommendedantigenicproteincontentlimitof10
µg/dm
2
inaccordancewith8.9andAnnexA2.
7.1.7Havearecommendedmaximumpowderlimitof15
mg/dm
2
inaccordancewith8.8.
eTestMethods
8.1Thefollowingtestsshallbeconductedtoassurethe
requirementsofSection7asprescribedinTable1:
8.2SterilityTest—Testingforsterilityshallbeconductedin
copeia.
8.3FreedomfromHoles—Testingforfreedomfromholes
shallbeconductedinaccordancewithTestMethodD5151.
8.4PhysicalDimensionsTest:
8.4.1Theglovesshallcomplywiththedimensionrequire-
mentsspecifiedinTable2.
8.4.2Thelengthshallbeexpressedinmillimetresasmea-
suredfromthetipofthesecondfingertotheoutsideedgeof
thecuff.
8.4.3Thewidthofthepalmshallbeexpressedinmillime-
tresasmeasuredatalevelbetweenthebaseoftheindexfinger
ofwidthpersizeotherthan
listedshallmeetthestatedtolerancespecifiedin
Table2.
--```,,,`,``,,`,,``````````,,,`-`-`,,`,,`,`,,`---
8.4.4Theminimumthicknessshallbeexpressedinmilli-
metresasspecifiedin
Table2whenusingadialmicrometer
describedinPracticeD3767andinthelocationsindicatedon
ereetests,cuttingthegloveisnecessarytoobtain
single-thicknessmeasurements.
8.4.5PrecisionandBias—Theprecisionandbiasofmea-
suringglovedimensionsareasspecifiedinPracticeD3767.
8.5PhysicalRequirementsTest:
8.5.1Beforeandafteracceleratedaging,theglovesshall
conformtothephysicalrequirementsspecifiedinTable3.
TestsshallbeconductedinaccordancewithTestMethods
D412.
8.5.2Acceleratedagingtestsshallbeconductedinaccor-
dancewithTestMethod
eglovesbyeitheroneof
thefollowingmethods:
8.5.2.1Afterbeingsubjectedtoatemperatureof7062°C
for16662h,thetensilestrengthandultimateelongationshall
notbelessthanthevaluesspecifiedin
thod
shallbetheconditionforrefereetests.
8.5.2.2Afterbeingsubjectedtoatemperatureof10062°C
for2260.3h,thetensilestrengthandultimateelongation
shallnotbelessthanthevaluesspecifiedin
Table3.
8.5.3PrecisionandBias—Theprecisionandbiasofdeter-
miningtensilestrengthandultimateelongationofglovesareas
specifiedinTestMethods
D412.
8.6PowderFreeGloves:
8.6.1DeterminethepowderresidueusingTestMethod
D6124.
8.7AqueousExtractableProteinContent:
8.7.1Determinetheaqueousextractableprotein(µg/mL)
usingTestMethod
D5712foreachglovesampletested.
8.7.2Determinethetotalµgofaqueousextractableprotein
ineachglovesamplebymultiplyingtheresultfrom
8.7.1by
thetotalvolumeofextractantusedforthatspecificglove
lovesampleislessthanawholeglove,then
adjusttheproteinresultstoreflecttheamountofproteininthe
wholeglove.
8.7.3Determinethesquaredecimetresfortheglovesize.
Multiplytheminimumlengthandnominalwidthfoundin
Table2andconverttodm
2
using(dm
2
/mm
2
)(mm
2
/10000).
Four(4)isthefactorforallinsideandoutsidesurfaceareas.
8.7.4Determinetheaqueousextractableproteincontentofa
glovesamplebydividingtheresultfrom
8.7.2(totalµgof
protein)by8.7.3(totalsurfaceareaofglove).
TABLE2DimensionsandTolerances
Designation
Length,mm
Width,mm
Thickness,mm:
Finger
Palm
Cuff
Size
5
1
⁄
2
245
70
6
265
76
6
1
⁄
2
265
83
7
265
89
7
1
⁄
2
265
95
8
265
102
8
1
⁄
2
265
108
9
265
114
Tolerance
min
66
0.10
0.10
0.10
min
min
min
2
2024年5月6日发(作者：郭明珠)
Designation:D3577–09
StandardSpecificationfor
RubberSurgicalGloves
1
ThisstandardisissuedunderthefixeddesignationD3577;thenumberimmediatelyfollowingthedesignationindicatestheyearof
originaladoptionor,inthecaseofrevision,rinparenthesesindicatestheyearoflastreapproval.A
superscriptepsilon(´)indicatesaneditorialchangesincethelastrevisionorreapproval.
ThisstandardhasbeenapprovedforusebyagenciesoftheDepartmentofDefense.
1.1Thisspecificationcoverscertainrequirementsforpack-
agedsterilerubbersurgicalglovesusedinconductingsurgical
procedures.
1.2ThevaluesstatedinSIunitsaretoberegardedas
runitsofmeasurementareincludedinthis
standard.
1.3Thefollowingsafetyhazardscaveatpertainsonlytothe
testmethodportion,Section8,ofthisspecification:This
standarddoesnotpurporttoaddressallofthesafetyconcerns,
ifany,eresponsibilityoftheuser
ofthisstandardtoestablishappropriatesafetyandhealth
practicesanddeterminetheapplicabilityofregulatorylimita-
tionspriortouse.
ncedDocuments
2.1ASTMStandards:
2
D412TestMethodsforVulcanizedRubberandThermo-
plasticElastomers—Tension
D573TestMethodforRubber—DeteriorationinanAir
Oven
D3767PracticeforRubber—MeasurementofDimensions
D5151TestMethodforDetectionofHolesinMedical
Gloves
D5712TestMethodforAnalysisofAqueousExtractable
ProteininNaturalRubberandItsProductsUsingthe
ModifiedLowryMethod
D6124TestMethodforResidualPowderonMedical
Gloves
D6499TestMethodforTheImmunologicalMeasurement
ofAntigenicProteininNaturalRubberanditsProducts
2.2Other
Documents:
--```,,,`,``,,`,,``````````,,,`-`-`,,`,,`,`,,`---
ISO2859SamplingProceduresandTablesforInspection
by
Attributes
3
copeia
4
fication
3.1Type1—Glovescompoundedprimarilyfromnatural
rubberlatex.
3.2Type2—Glovescompoundedfromarubbercementor
fromsyntheticrubberlatex.
alsandManufacture
4.1Anyrubberpolymercompoundthatpermitsthegloveto
meettherequirementsofthisspecification.
4.2Alubricantthatmeetsthecurrentrequirementsofthe
copeiaforAbsorbableDustingPowdermaybe
applied
ubricantsmaybeusediftheir
safetyandefficacyhavebeenpreviouslyestablished.
4.3Theinsideandoutsidesurfaceoftherubbersurgical
glovesshallbefreeoftalc.
ficanceandUse
5.1Thespecificationisintendedasareferencetothe
eand
properuseofrubbersurgicalglovesisbeyondthescopeofthis
specification.
ng
6.1Forrefereepurposes,glovesshallbesampledand
pectionlevels
and
acceptablequalitylevels(AQL)shallconformtothose
specifiedinTable1,orasagreedbetweenthepurchaserandthe
seller,ifthelatterismorecomprehensive.
manceRequirements
7.1Gloves,sampledinaccordancewithSection6,shall
meetthefollowingrefereeperformancerequirements:
7.1.1Complywithrequirementsforsterilitywhentestedin
accordancewith8.2.
AvailablefromAmericanNationalStandardsInstitute,25West43rdSt.,4th
Floor,NewYork,NY10036.
4
copeia,latestedition,MackPublishingCo.,Easton,PA19175.
3
ThisspecificationisunderthejurisdictionofASTMCommitteeD11onRubber
andisthedirectresponsibilityofSubcommitteeD11.40onConsumerRubber
Products.
CurrenteditionapprovedJan.1,ally
eviouseditionapprovedin2006asD3577–06.
2
ForreferencedASTMstandards,visittheASTMwebsite,,or
contactASTMCustomerServiceatservice@ualBookofASTM
Standardsvolumeinformation,refertothestandard’sDocumentSummarypageon
theASTMwebsite.
1
Copyright©ASTMInternational,100BarrHarborDrive,POBoxC700,WestConshohocken,PA19428-2959,UnitedStates.
1
D3577–09
TABLE1PerformanceRequirements
Characteristic
Sterility
Freedomfromholes
Physicaldimensions
Physicalproperties
PowderFreeResidue
ProteinContent
PowderAmount
AntigenicProtein
Content
A
RelatedDefects
failssterility
holes
length,width,and
thickness
beforeaging,afteraccel-
eratedaging
ExceedsMaximumLimit
ExceedsRecommended
MaximumLimit
ExceedsRecommended
MaximumLimit
ExceedsRecommended
MaximumLimit
Inspection
Level
A
AQL
N/A
1.5
4.0
4.0
N/A
N/A
N/A
N/A
I
S-2
S-2
N=5
N=3
N=2
N=1
copeia.
7.1.2Befreefromholeswhentestedinaccordancewith8.3.
7.1.3Haveconsistentphysicaldimensionsinaccordance
with8.4.
7.1.4Haveacceptablephysicalpropertycharacteristicsin
accordancewith8.5.
7.1.5Haveapowderresiduelimitof2.0mginaccordance
with8.6.
7.1.6Havearecommendedaqueoussolubleproteincontent
limitof200µg/dm
2
inaccordancewith8.7andAnnexA1or
havearecommendedantigenicproteincontentlimitof10
µg/dm
2
inaccordancewith8.9andAnnexA2.
7.1.7Havearecommendedmaximumpowderlimitof15
mg/dm
2
inaccordancewith8.8.
eTestMethods
8.1Thefollowingtestsshallbeconductedtoassurethe
requirementsofSection7asprescribedinTable1:
8.2SterilityTest—Testingforsterilityshallbeconductedin
copeia.
8.3FreedomfromHoles—Testingforfreedomfromholes
shallbeconductedinaccordancewithTestMethodD5151.
8.4PhysicalDimensionsTest:
8.4.1Theglovesshallcomplywiththedimensionrequire-
mentsspecifiedinTable2.
8.4.2Thelengthshallbeexpressedinmillimetresasmea-
suredfromthetipofthesecondfingertotheoutsideedgeof
thecuff.
8.4.3Thewidthofthepalmshallbeexpressedinmillime-
tresasmeasuredatalevelbetweenthebaseoftheindexfinger
ofwidthpersizeotherthan
listedshallmeetthestatedtolerancespecifiedin
Table2.
--```,,,`,``,,`,,``````````,,,`-`-`,,`,,`,`,,`---
8.4.4Theminimumthicknessshallbeexpressedinmilli-
metresasspecifiedin
Table2whenusingadialmicrometer
describedinPracticeD3767andinthelocationsindicatedon
ereetests,cuttingthegloveisnecessarytoobtain
single-thicknessmeasurements.
8.4.5PrecisionandBias—Theprecisionandbiasofmea-
suringglovedimensionsareasspecifiedinPracticeD3767.
8.5PhysicalRequirementsTest:
8.5.1Beforeandafteracceleratedaging,theglovesshall
conformtothephysicalrequirementsspecifiedinTable3.
TestsshallbeconductedinaccordancewithTestMethods
D412.
8.5.2Acceleratedagingtestsshallbeconductedinaccor-
dancewithTestMethod
eglovesbyeitheroneof
thefollowingmethods:
8.5.2.1Afterbeingsubjectedtoatemperatureof7062°C
for16662h,thetensilestrengthandultimateelongationshall
notbelessthanthevaluesspecifiedin
thod
shallbetheconditionforrefereetests.
8.5.2.2Afterbeingsubjectedtoatemperatureof10062°C
for2260.3h,thetensilestrengthandultimateelongation
shallnotbelessthanthevaluesspecifiedin
Table3.
8.5.3PrecisionandBias—Theprecisionandbiasofdeter-
miningtensilestrengthandultimateelongationofglovesareas
specifiedinTestMethods
D412.
8.6PowderFreeGloves:
8.6.1DeterminethepowderresidueusingTestMethod
D6124.
8.7AqueousExtractableProteinContent:
8.7.1Determinetheaqueousextractableprotein(µg/mL)
usingTestMethod
D5712foreachglovesampletested.
8.7.2Determinethetotalµgofaqueousextractableprotein
ineachglovesamplebymultiplyingtheresultfrom
8.7.1by
thetotalvolumeofextractantusedforthatspecificglove
lovesampleislessthanawholeglove,then
adjusttheproteinresultstoreflecttheamountofproteininthe
wholeglove.
8.7.3Determinethesquaredecimetresfortheglovesize.
Multiplytheminimumlengthandnominalwidthfoundin
Table2andconverttodm
2
using(dm
2
/mm
2
)(mm
2
/10000).
Four(4)isthefactorforallinsideandoutsidesurfaceareas.
8.7.4Determinetheaqueousextractableproteincontentofa
glovesamplebydividingtheresultfrom
8.7.2(totalµgof
protein)by8.7.3(totalsurfaceareaofglove).
TABLE2DimensionsandTolerances
Designation
Length,mm
Width,mm
Thickness,mm:
Finger
Palm
Cuff
Size
5
1
⁄
2
245
70
6
265
76
6
1
⁄
2
265
83
7
265
89
7
1
⁄
2
265
95
8
265
102
8
1
⁄
2
265
108
9
265
114
Tolerance
min
66
0.10
0.10
0.10
min
min
min
2