D1100000606001 Food Sevice Gloves

8/2/2019 D1100000606001 Food Sevice Gloves

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Draft Standard

WK945TO: Members of D11

Re: WK945

Attached please find theStandard Specification for Food Preparation and Food Handling

(Food Service) Gloves that is being submitted to ASTM for balloting to D11 Main Committee.

Tito AldapeChairman

Food Service Gloves

Cc: Kok-Kee Hon

D11.40 Chairman


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Draft Standard

WK945Standard Specification for Food Preparation and Food Handling (Food Service)

Gloves1

1. Scope

1.1 This standard describes the properties necessary for thin film, unlined polymergloves to be used in food preparation and food handling.

1.2 This specification is intended to serve as a referee and a guide to permit obtaining

gloves of a consistent performance. The safe and proper use of gloves is excludedfrom the scope of this specification.

1.3 This standard does not purport to address all of the safety concerns associates

with the use of particular gloves that met this standard. It is the responsibility ofthe user of this standard to establish appropriate safety and health practices to

determine the applicability of material limitations prior to use.

2. Referenced Documents

2.1 ASTM Standards

ASTM D 412 Test Methods for Vulcanized Rubber and Thermoplastic Rubbers

and Thermoplastic Elastomers-Tension2

ASTM D 573 Test Method for Rubber-Deterioration in an Air Oven2

ASTM D 882 Standard Test for Tensile Properties of Thin Plastic Sheeting

ASTM D 3578 Specification for Rubber Examination Gloves3

ASTM D 3767 Practice for Rubber-Measurement of Dimensions2

ASTM D 4679 Specification for Rubber General Purpose, Household or

Beautician Gloves3

ASTM D 5151 Test Method for Detection of Holes in Medical Gloves3

ASTM D 5250 Specification for Vinyl (PVC) Examination Gloves

3

ASTM D 5712 Standard Test Method for the Analysis of Aqueous Extractable

Protein in Natural Rubber and Its Products Using the Modified Lowry Method2

ASTM D 6124 Test Method for Residual Powder on Medical Gloves3

ASTM D 6319 Specification for Nitrile Examination Gloves for

Medical Application

Gloves3

ASTM D 7246 Standard Test Method for the Detection of Holes in Polyethylene

Food Service Gloves Standard Test Method for Detection of Holes in Food

Service and General Purpose Gloves

2.2 ISO Standards

ISO 2859-1 Sampling Procedures and Tables for Inspection by Attributes4

1 This specification is under the jurisdiction of ASTM Committee D11 on Rubber and is the direct responsibility of

Subcommittee D11.40 , Consumer Rubber Products.2 Annual Book of ASTM Standards Vol. 09.013 Annual Book of ASTM Standards Vol 09.02


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2.3 Code of Federal Regulations - Title 21 - Food and Drugs U.S. Food and Drug

Regulations codified in the U.S. Code of Regulations

21CFR172 Food Additives Permitted for Direct Addition to Food for Human

Consumption

5

21CFR177.1350 Ethylene-vinyl acetate copolymers.21CFR177.1480 Nitrile Rubber Modified Acrylnitrile-methyl Acrylate Co-

polymers

21CFR177.1600 Polyethylene copolymers21CFR177.1950 Vinyl chloride-ethylene copolymers.

21CFR177.1980 Vinyl chloride-propylene copolymers.

21CFR177.2600 Rubber Articles Intended for Repeated Use21CFR184 Direct Food Substances Affirmed as Generally Recognized As Safe

3. Materials and Manufacture

3.1 Any material or composition that permits the glove to meet the specification

identified by this standard and comply with the requirements of this specification

and the regulations promulgated by the U.S. Food and Drug Administrationconcerning the materials used and permitted for direct food contact and the

regulations concerning any powder or lubricants added to the gloves are

acceptable.

4. Performance Requirements

4.1 Gloves shall be sampled in accordance with the AQL specified in Table 1 using a

sampling plan derived from ISO 2859-1 or its equivalent, or other suitablestatistical rationale.

4.2 Gloves shall be tested for freedom of holes as described in Section 5.1 andcomply with the requirements of Table 1 for freedom from holes.

4.3 Gloves shall meet andbe tested forphysical dDimensions and Tolerances as

described in Section 5.2 and comply with the Performance rRequirements of

listed in Table 1 forphysical dDimensions.4.4 Gloves shall meet andbe tested forpPhysicalpProperties as described in Section

5.3 and comply with the Performance rRequirements of listed in Table 2 1 for

pPhysicalpProperties.4.5 Powder Free Ggloves shall be tested for glove powder residue per Section 5.4 and

comply with 21CFR172, 21CFR177 (as applicable), and 21CFR184 for the

collected residue.4.6 Powdered gloves shall be tested for glove powder amounts per Section 5.4 and

comply with 21CFR172, 21CFR177 (as applicable), and 21CFR184 for the

collected residue.4.64.7 Protein:

4 Available from American National Standards Institute 25 W. 43rd St. 4th Floor, New York, NY 100365 Available from the Government Printing Office, http://www.access.gpo.gov/nara/cfr/cfr-table-search.html


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Draft Standard

WK9454.7.1 Gloves made from natural rubber and powders shall be tested for compliance

to the recommended aqueous soluble protein content limit residual proteins as

described in Section 5.56.

4.7.2 Or, tested for compliance to the recommended antigenic protein content limitas described in Section 5.7.

5. Referee Test Methods5.1 Holes - Gloves shall be tested in accordance with ASTM D 5151 to an AQL of

2.5 as specified in Table 1 oras required by each materials existing material

specific ASTM glove standard. Plastic5.1.1 Polyethylene gloves, or gloves made from materials not covered by an

existing ASTM standard as of the date this standard is issued designed for

food service shall be testedpursuant tousing Test Method ASTM D 7246 toan AQL of 2.5 as specified in Table 1.

5.1.2 Food service gloves made of a material type not described and/or specified inan existing ASTM glove standard and the material is non-elastic, then Test

Method ASTM D 7246 shall be used for the detection of holes to an AQL of2.5 as specified in Table 1.

5.2 Dimensions - Gloves shall be tested forPhysicalDimensions and Tolerancesinaccordance with their individual standards or ASTM D 3767 to an AQL of 4.0per

Table 1 and as specified in Tables32a through 2f. Measurement Llocations are

specified in Figure 1.

5.2.1 Dimensions shall be expressed in millimeters (mm)

5.2.2 Values shall meet the requirements established in Table 3

5.2.3 Should thickness be specified by the customerWhen the customer specifies

thickness, it shall be measured using an appropriate instrument to measurethickness in accordance with D 412 and D 3767 in the location specified in

Figure 1.

5.3 Physical Properties - Gloves shall be tested for physical properties as described

ASTM D 412 to and AQL 4.0per Table 1 and as specified in Tables 3a through

3h. Should aAccelerated agingbe required specified by the customer, it shall beconducted in accordance with ASTM D 573. Accelerated aging shall be

conducted at 70 C +/- 2 C for a period of 168 +/- 2 hours +/- 2 on gloves that are

no more than 12 months old from the manufacturing datedate of manufacture.5.4 Powder(Powder Free Gloves) - Gloves shall be tested for residual powders in

accordance with D 6124. Food Service Gloves labeled to beas pPowderfFree

shall contain no more than 2 mgadhere to the powder residue limit established inASTM D 3578. of residue powder per D 6124. All glovepowders shall comply

with 21CFR172 and 21CFR184.No Apowder, release agent, or lubricant not

listed in either 21CFR172 or 21CFR184 shall notbe used for gloves designedto contact food products. Powder levels on the gloves shall not exceed the levels

established in D3578.


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Draft Standard

WK9455.5 Powder (Powdered Gloves) - Gloves shall be tested for maximum powder limit

using Test Method ASTM D 6124. Powdered Food Service Gloves shall adhere

to the maximum powder limit established in ASTM D 3578. All glove powders

shall comply with 21CFR172 and 21CFR184. A powder, release agent, orlubricant not listed in either 21CFR172 or 21CFR184 shall not be used for gloves

designed to contact food products.5.6 Aqueous Extractable Protein Content For Ggloves made from natural rubber,

determine the shall be tested for aqueous extractableprotein (g/mL) contentforeach glove sample tested using Test Method , if applicable to the material, in

accordance with ASTM D5712. The level of soluble protein shall not exceed 200

g/dm2. Have a recommended aqueous soluble protein content limit (measured in

g/dm2) in accordance with ASTM D 3578 or have a recommended antigenic

protein content limit (see Section 5.7) in accordance with ASTM D 3578.

5.7 Antigenic Protein Content For gloves made from natural rubber determine the

extractable antigenic protein (g/mL) for each glove sample tested using TestMethod ASTM D 6499. Have a recommended antigenic protein content limit

(measured in g/dm2

) in accordance with ASTM D 3578 or have recommendedaqueous soluble protein content limit (see Section 5.6) in accordance with ASTMD 3578.

5.5

5.65.8 Design -. Any glove design meeting the requirements of this standard and the

suitable for direct food contact may be used.

6. Quality Assurance

6.1 Responsibility for Inspection. When specified in the contract or purchase order,

the supplier is responsible for performance of all inspection requirements.

6.2 Gloves will be considered to meet the referee performance requirements when thetest results do not exceedmeet the AQL Performance Requirements found inTable 1.

6.3 Retests are permissible under the provisions of ISO 2859 with a documented

statistical rationale.

7. Product Marking

7.1 Glove identification. - Each consumer package of gloves shall at a minimum be

legibly marked to include thewith the following information: size, the name or

and trademark(if applicable) of the manufactureror supplier, the manufacturers

lot code number, manufacturers or suppliers contact information, and thecountry of origin.

8. Packaging and Storage

8.1 The gloves shall be packaged in a manner sufficient to protect them against

degradation. All packaging materials in direct contact with product surfaces shall


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Draft Standard

WK945be approved for food contact, and protect products from damage during

transportation and storage.

8.2 No packaging material in contact with gloves is to contain substances that will

impair the quality or use of the gloves.8.3 All labeling for gloves compliant with the this standard shall also comply with

applicable government regulations. , and unless otherwise specified inaccordance with the manufacturers standard commercial practices.8.4 Gloves shall be labeled appropriately to avoid contact with materials that may

degrade the gloves in use, compromise the barrier, or are otherwise harmful to the

glove material. Limitations of the materials affecting the use of the glove shall belabeled or made available to the end user.

8.5 Gloves shall be protected from exposure to light and excessive heat in storage or

any other environmental condition that may compromise the material. Suchlabeling shall be consistent with the applicable standard for the material. Storage

Ttemperaturesbelow shall not exceed 40 C are recommended.8.6 Gloves compliant with this standard may be labeled with a statement that the

gloves comply with this ASTM standard.

9. Keywords

9.1 Food contact, gloves, natural rubber, synthetic rubber, vinyl andplasticpolyethylene.

TABLE 1

Performance Requirements

Characteristic Related Defect Inspection Level AQL

Freedom from Holes holes G-1 2.5Dimensions width, length, and S-2 4.0

if required, thickness

Physical Properties before aging, afteraging S-2 4.0accelerated aging

PowderFree Residue Exceeds Maximum lLimit N=5 N/A

Powder Amount Exceeds Recommended N=2 N/AMaximumu Limit

Protein Content (Natural Rubber) Exceeds Recommended N=3 N/A

Maximum LimitAntigenic Protein Exceeds Recommended N=1 N/A

Content (Natural Rubber) Maximum Limit

TABLE 1I

Dimensions and Tolerances


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Draft Standard

WK945Designation x-small small unisize medium large x-large xx-large Tolerance, mm

Width by Size 75 83 89 95 102 104 114 +/- 6

Width by x-small small unisize medium large X-large XX-Large +/- 10

70 80 85 95 110 120 130

Length 220 220 230 230 230 230 230 min

Thickness per material standard (if specified) or

All sizes

Finger 0.08 minPalm 0.08 min

Cuff 0.08 min

TABLE 2a Dimensions and Tolerances: Natural Rubber (Latex)

Size

Designation 6 6 7 7 8 8 9 Tolerance, mmWidth by size 75 83 89 95 102 108 114 +/- 6

Width by x-small small Unisize medium large X-large XX-large70 80 85 95 110 120 130 +/- 10

ength 240 240 240 240 240 240 240 Min

hickness.mm: For All SizesFinger 0.08 Min

Palm 0.08 Min.Cuff 0.08 Min

ote 1 Sizing that falls within the tolerance overlaps between two sizes may be labeled as a size range including both sizes, for example, small/medium and medium/large.

TABLE 2b Dimensions and Tolerances: Synthetic Rubber; Polychloroprene and Nitrile

Size

Designation 6 6 7 7 8 8 9 ToleranceWidth by size 75 83 89 95 102 108 114 +


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WK945

Width by x-small small Unisize medium large X-large XX-large70 80 85 95 110 120 130 +

ength 240 240 240 240 240 240 240 Min


Palm 0.05 Min.Cuff 0.05 Min


TABLE 2c Dimensions and Tolerances: Vinyl (PVC)

Size

Designation 6 6 7 7 8 8 9 Tolerance, mm

Width by size 75 83 89 95 102 108 114 +/- 6

Width by x-small small Unisize medium large X-large XX-large70 80 85 95 110 120 130 +/- 10

ength 240 240 240 240 240 240 240 Min

hickness.mm: For All SizesFinger 0.05 MinPalm 0.08 Min.Cuff 0.05 Min


TABLE 2d Dimensions and Tolerances: Low Density Polyethylene (LDPE)

Size

DesignationWidth by x-small small medium large X-largeRange (mm) 95-135 100-140 105-155 110-165 120-170


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ength (mm) 250 250 260 265 265 Min


Palm 0.0185 Min.

Cuff 0.0185 Min


TABLE 2e Dimensions and Tolerances: High Density Polyethylene (HDPE)

Size

DesignationWidth by x-small small medium large X-largeRange (mm) 125-160 135-170 145-180 155-190 165-200

ength (mm) 210 210 210 210 210 Min

hickness.mm: For All SizesFinger 0.016 MinPalm 0.016 Min.

Cuff 0.016 Min


TABLE 2f Dimensions and Tolerances: Cast Polyethylene (CPE)

Size

Designation

Width by x-small small medium large X-largeRange (mm) 100-135 100-145 115-155 130-165 135-170

ength (mm) 285 285 300 300 300 Min

hickness.mm: For All SizesFinger 0.024 MinPalm 0.024 Min.

Cuff 0.024 Min


TABLE 3a Physical Requirements for Natural Rubber (Type I)

Before Aging After Accelerated AgingTensile Strength Ultimate Elongation Tensile Strength Ultimate Elongation

18 MPa min 650% min 14 MPa min 500 % min


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TABLE 3b Physical Requirements for Natural Rubber (Type II)

Before Aging After Accelerated Aging

Tensile Strength Ultimate Elongation Tensile Strength Ultimate Elongation14 MPa min 650% min 14 MPa min 500 % min

TABLE 3c Physical Requirements for Synthetic Rubber: Polychloroprene


Tensile Strength Ultimate Elongation Tensile Strength Ultimate Elongation14 MPa min 500% min 14 MPa min 400 % min

TABLE 3d Physical Requirements for Synthetic Rubber: Nitrile



TABLE 3e Physical Requirements for Vinyl (PVC)



TABLE 3f Physical Requirements for Low Density Polyethylene (LDPE)


Tensile Strength Ultimate Elongation Tensile Strength Ultimate Elongation280 N/m min 500% min 280N/m min 500 % min

TABLE 3g Physical Requirements for High Density Polyethylene (HDPE)


320 N/m min 500% min 320 N/m min 500 % min

TABLE 3h Physical Requirements for Cast Polyethylene (CPE)


Tensile Strength Ultimate Elongation Tensile Strength Ultimate Elongation360 N/m min 300% min 360 N/m min 300 % min

Figure 1. Glove Measurement Locations


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TABLE II1

Physical Requirements (all values minimums)

Characteristic Before Aging After Accelerated Aging

UltimateTensile Strength Ultimate Elongation Tensile Strength Elongation

Plastic/ polyethylene 300% 9.0 MPa 300%

Natural Rubber 650% 14 MPa 500%Synthetic Rubber, all types 500% 7.5 MPa 375%

Vinyl 300% 9.0 MPa 300%

Figure 1


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Draft Standard

WK945