Draft Standard WK945

TO: Members of D11

Re: WK945

Attached please find the Standard Specification for Food Preparation and Food Handling (Food Service) Gloves that is being submitted to ASTM for balloting to D11 Main Committee. Tito Aldape Chairman Food Service Gloves Cc: Kok-Kee Hon D11.40 Chairman

Draft Standard WK945

Standard Specification for Food Preparation and Food Handling (Food Service) Gloves1
1. Scope 1.1 1.2 This standard describes the properties necessary for thin film, unlined polymer gloves to be used in food preparation and food handling. 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 excluded from the scope of this specification. 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 of the user of this standard to establish appropriate safety and health practices to determine the applicability of material limitations prior to use.

1.3

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 Oven 2 ASTM D 882 Standard Test for Tensile Properties of Thin Plastic Sheeting ASTM D 3578 Specification for Rubber Examination Gloves 3 ASTM D 3767 Practice for Rubber-Measurement of Dimensions 2 ASTM D 4679 Specification for Rubber General Purpose, Household or Beautician Gloves 3 ASTM D 5151 Test Method for Detection of Holes in Medical Gloves 3 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 Method 2 ASTM D 6124 Test Method for Residual Powder on Medical Gloves 3 ASTM D 6319 Specification for Nitrile Examination Gloves for Medical Application Gloves 3 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

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. 09.01 3 Annual Book of ASTM Standards Vol 09.02

Draft Standard WK945

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 21 CFR 172 Food Additives Permitted for Direct Addition to Food for Human Consumption5 21 CFR 177.1350 Ethylene-vinyl acetate copolymers. 21 CFR 177.1480 Nitrile Rubber Modified Acrylnitrile-methyl Acrylate Copolymers 21 CFR 177.1600 Polyethylene copolymers 21 CFR 177.1950 Vinyl chloride-ethylene copolymers. 21 CFR 177.1980 Vinyl chloride-propylene copolymers. 21 CFR 177.2600 Rubber Articles Intended for Repeated Use 21 CFR 184 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 Administration concerning 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 suitable statistical rationale. 4.2 Gloves shall be tested for freedom of holes as described in Section 5.1 and comply with the requirements of Table 1 for freedom from holes. 4.3 Gloves shall meet and be tested for physical dDimensions and Tolerances as described in Section 5.2 and comply with the Performance rRequirements of listed in Table 1 for physical dDimensions. 4.4 Gloves shall meet and be tested for pPhysical pProperties as described in Section 5.3 and comply with the Performance rRequirements of listed in Table 2 1 for pPhysical pProperties. 4.5 Powder Free Ggloves shall be tested for glove powder residue per Section 5.4 and comply with 21 CFR 172, 21 CFR 177 (as applicable), and 21 CFR 184 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 5

Available from American National Standards Institute 25 W. 43rd St. 4th Floor, New York, NY 10036 Available from the Government Printing Office, http://www.access.gpo.gov/nara/cfr/cfr-table-search.html

Draft Standard WK945

4.7.1 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. Or, tested for compliance to the recommended antigenic protein content limit as described in Section 5.7.

4.7.2

5.

Referee Test Methods 5.1 Holes - Gloves shall be tested in accordance with ASTM D 5151 to an AQL of 2.5 as specified in Table 1 or as required by each materials existing material specific ASTM glove standard. Plastic 5.1.1 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 tested pursuant tousing Test Method ASTM D 7246 to an 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 in an 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 of 2.5 as specified in Table 1. 5.2 Dimensions - Gloves shall be tested for Physical Dimensions and Tolerances in accordance with their individual standards or ASTM D 3767 to an AQL of 4.0 per Table 1 and as specified in Tables 32a 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 measure thickness 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 4.0 per Table 1 and as specified in Tables 3a through 3h. Should aAccelerated aging be required specified by the customer, it shall be conducted 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. Powder (Powder Free Gloves) - Gloves shall be tested for residual powders in accordance with D 6124. Food Service Gloves labeled to beas pPowder fFree shall contain no more than 2 mgadhere to the powder residue limit established in ASTM D 3578. of residue powder per D 6124. All glove powders shall comply with 21 CFR 172 and 21 CFR 184. No A powder, release agent, or lubricant not listed in either 21 CFR 172 or 21 CFR 184 shall not be used for gloves designed to contact food products. Powder levels on the gloves shall not exceed the levels established in D3578.

5.4

Draft Standard WK945

5.5 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, or lubricant not listed in either 21CFR172 or 21CFR184 shall not be used for gloves designed to contact food products. Aqueous Extractable Protein Content For Ggloves made from natural rubber, determine the shall be tested for aqueous extractable protein (g/mL) contentfor each glove sample tested using Test Method , if applicable to the material, in accordance with ASTM D 5712. 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. Antigenic Protein Content For gloves made from natural rubber determine the extractable antigenic protein (g/mL) for each glove sample tested using Test Method ASTM D 6499. Have a recommended antigenic protein content limit (measured in g/dm2) in accordance with ASTM D 3578 or have recommended aqueous soluble protein content limit (see Section 5.6) in accordance with ASTM D 3578.

5.6

5.7

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 6.2 Responsibility for Inspection. When specified in the contract or purchase order, the supplier is responsible for performance of all inspection requirements. Gloves will be considered to meet the referee performance requirements when the test results do not exceedmeet the AQL Performance Requirements found in Table 1. Retests are permissible under the provisions of ISO 2859 with a documented statistical rationale.

6.3

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 manufacturer or supplier, the manufacturers lot code number, manufacturers or suppliers contact information, and the country 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

Draft Standard WK945

8.2 8.3 be approved for food contact, and protect products from damage during transportation and storage. No packaging material in contact with gloves is to contain substances that will impair the quality or use of the gloves. All labeling for gloves compliant with the this standard shall also comply with applicable government regulations. , and unless otherwise specified in accordance with the manufacturers standard commercial practices. 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 be labeled or made available to the end user. Gloves shall be protected from exposure to light and excessive heat in storage or any other environmental condition that may compromise the material. Such labeling shall be consistent with the applicable standard for the material. Storage Ttemperatures below shall not exceed 40 C are recommended. Gloves compliant with this standard may be labeled with a statement that the gloves comply with this ASTM standard.

8.4

8.5

8.6

9.

Keywords 9.1 Food contact, gloves, natural rubber, synthetic rubber, vinyl and plasticpolyethylene.

Characteristic Freedom from Holes Dimensions Physical Properties Powder Free Residue Powder Amount Protein Content (Natural Rubber) Antigenic Protein Content (Natural Rubber)

TABLE 1 Performance Requirements Related Defect Inspection Level holes width, length, and if required, thickness before aging, after aging accelerated aging Exceeds Maximum lLimit Exceeds Recommended Maximumu Limit Exceeds Recommended Maximum Limit Exceeds Recommended Maximum Limit G-1 S-2 S-2 N=5 N=2 N=3 N=1

AQL 2.5 4.0 4.0 N/A N/A N/A N/A

TABLE 1I Dimensions and Tolerances

Draft Standard WK945

Designation Width by Size Width by 75
x-small small unisize medium large x-large xx-large

Tolerance, mm +/- 6 +/- 10

83

89

95

102

104

114
X-large XX-Large

x-small small

unisize medium large

70 Length 220

80 220

85 230

95 230

110 230

120 230

130 230 min

Thickness per material standard (if specified) or All sizes Finger 0.08 Palm 0.08 Cuff 0.08

min min min

Designation Width by size Width by

6 75

TABLE 2a Dimensions and Tolerances: Natural Rubber (Latex) Size 6 7 7 8 8 9 83 89 95 102 108 114 medium 95 240 large 110 240 For All Sizes 0.08 0.08 0.08 X-large 120 240 XX-large 130 240

Tolerance, mm +/- 6

x-small small Unisize 70 80 85 240 240 240

+/- 10 Min

Length Thickness.mm: Finger Palm Cuff

Min Min. Min

Note 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.

Designation Width by size

TABLE 2b Dimensions and Tolerances: Synthetic Rubber; Polychloroprene and Nitrile Size 6 6 7 7 8 8 9 75 83 89 95 102 108 114

Tolerance, mm +/- 6

Draft Standard WK945

Width by x-small small Unisize 70 80 85 240 240 240 medium 95 240 large 110 240 For All Sizes 0.05 0.05 0.05 X-large 120 240 XX-large 130 240 Min +/- 10

Length Thickness.mm: Finger Palm Cuff

Min Min. Min

Note 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.

Designation Width by size Width by

6 75

6 83

TABLE 2c Dimensions and Tolerances: Vinyl (PVC) Size 7 7 8 8 9 89 95 102 108 114 medium 95 240 large 110 240 For All Sizes 0.05 0.08 0.05 X-large 120 240 XX-large 130 240

Tolerance, mm +/- 6

x-small small Unisize 70 80 85 240 240 240

+/- 10 Min

Length Thickness.mm: Finger Palm Cuff

Min Min. Min

Note 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 2d Dimensions and Tolerances: Low Density Polyethylene (LDPE) Size Designation Width by Range (mm) x-small 95-135 small 100-140 medium 105-155 large 110-165 X-large 120-170

Draft Standard WK945

Length (mm) Thickness.mm: Finger Palm Cuff 250 250 260 For All Sizes 0.0185 0.0185 0.0185 265 265 Min

Min Min. Min

Note 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 2e Dimensions and Tolerances: High Density Polyethylene (HDPE) Size Designation Width by Range (mm) Length (mm) Thickness.mm: Finger Palm Cuff x-small 125-160 210 small 135-170 210 medium 145-180 210 For All Sizes 0.016 0.016 0.016 large 155-190 210 X-large 165-200 210 Min

Min Min. Min

Note 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 2f Dimensions and Tolerances: Cast Polyethylene (CPE) Size Designation Width by Range (mm) Length (mm) Thickness.mm: Finger Palm Cuff x-small 100-135 285 small 100-145 285 medium 115-155 300 For All Sizes 0.024 0.024 0.024 large 130-165 300 X-large 135-170 300 Min

Min Min. Min

Note 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 3a Physical Requirements for Natural Rubber (Type I) Before Aging After Accelerated Aging Tensile Strength Ultimate Elongation Tensile Strength Ultimate Elongation 18 MPa min 650% min 14 MPa min 500 % min

Draft Standard WK945

TABLE 3b Physical Requirements for Natural Rubber (Type II) Before Aging After Accelerated Aging Tensile Strength Ultimate Elongation Tensile Strength Ultimate Elongation 14 MPa min 650% min 14 MPa min 500 % min TABLE 3c Physical Requirements for Synthetic Rubber: Polychloroprene Before Aging After Accelerated Aging Tensile Strength Ultimate Elongation Tensile Strength Ultimate Elongation 14 MPa min 500% min 14 MPa min 400 % min TABLE 3d Physical Requirements for Synthetic Rubber: Nitrile Before Aging After Accelerated Aging Tensile Strength Ultimate Elongation Tensile Strength Ultimate Elongation 14 MPa min 500% min 14 MPa min 400 % min TABLE 3e Physical Requirements for Vinyl (PVC) Before Aging After Accelerated Aging Tensile Strength Ultimate Elongation Tensile Strength Ultimate Elongation 9 MPa min 300% min 9 MPa min 300 % min TABLE 3f Physical Requirements for Low Density Polyethylene (LDPE) Before Aging After Accelerated Aging Tensile Strength Ultimate Elongation Tensile Strength Ultimate Elongation 280 N/m min 500% min 280N/m min 500 % min TABLE 3g Physical Requirements for High Density Polyethylene (HDPE) Before Aging After Accelerated Aging Tensile Strength Ultimate Elongation Tensile Strength Ultimate Elongation 320 N/m min 500% min 320 N/m min 500 % min TABLE 3h Physical Requirements for Cast Polyethylene (CPE) Before Aging After Accelerated Aging Tensile Strength Ultimate Elongation Tensile Strength Ultimate Elongation 360 N/m min 300% min 360 N/m min 300 % min

Figure 1. Glove Measurement Locations

Draft Standard WK945

Characteristic Tensile Strength

TABLE II1 Physical Requirements (all values minimums) Before Aging After Accelerated Aging Ultimate Ultimate Elongation Tensile Strength Elongation 300% 650% 500% 300% 9.0 MPa 14 MPa 7.5 MPa 9.0 MPa 300% 500% 375% 300%

Plastic/ polyethylene Natural Rubber Synthetic Rubber, all types Vinyl

Figure 1

Draft Standard WK945