1、 October 2005 NSF Protocol P155 Disposable Food Contact Gloves October 2005NSF International, an independent, not-for-profit organization, is dedicated to public health safety and protection of the environment by developing standards, by providing education and by providing superior third-party conf
2、ormity assessment services while representing the interest of all stakeholders. This Protocol is subject to revision. Contact NSF to confirm this revision is current. Users of this Protocol may request clarifications and interpretations, or propose revisions by contacting: NSF International Engineer
3、ing NSF Certification Mark and appropriate descriptor box; Number of items in the container; Country of origin; Adequate directions for use, include reference to hand washing prior to usage; “Powdered” or “Powder-Free”, if appropriate; Specification for donning powder (e.g. USP corn starch) Lot numb
4、er. 4.5.1 Natural rubber latex labeling If product is made from natural rubber latex, the following statement shall appear on packaging: Caution: This product contains natural rubber latex which may cause allergic reactions. 4.6 ISO compliance Each manufacturing facility shall be certified to ISO 90
5、02 by a nationally accredited, third-party certifying body. 5 Material-Specific Requirements 5.1 Polyethylene gloves Polyethylene gloves are made of plastic resins extruded into lightweight sheet films. Two sheets of polyethylene film are seamed or heat-sealed to form the glove. Polyethylene gloves
6、are non-powdered and designed for single tasks offering flexibility, loose fit, low cost, and ease of donning. Low Density Polyethylene (LDPE), Cast Polyethylene (CPE) and High Density Polyethylene (HDPE) material is manufactured with different resins and extrusion processes to give the gloves chara
7、cteristics for texture and softness. NSF P155 5 2005 NSF Polyethylene gloves shall meet the dimensional, physical, and quality requirements shown in Table I when tested according to Section 6.5 through 6.7. 5.2 Vinyl and vinyl blend gloves Vinyl gloves are made of polyvinyl chloride (PVC) material.
8、These gloves are formed by dipping a hand mold into the PVC to form a seamless glove. PVC gloves are more durable and closer-fitting than polyethylene for general food production where tactile sensitivity is important. Other synthetic glove materials are made from different formulations of PVC (e.g.
9、 Synthetic Vinyl Blend I) for characteristics such elasticity and strength. PVC and vinyl blend gloves shall meet the dimensional, physical, and quality requirements shown in Table I when tested according to Section 6.5 through 6.7. 5.3 Natural rubber latex gloves Natural rubber latex (NRL) gloves a
10、re made from a milky fluid derived from the rubber tree (Hevea brasiliensis). The gloves are formed by dipping a hand mold into the latex to form a seamless glove. They are ultra form-fitting offering very high dexterity and elasticity. Natural proteins in the latex can cause allergic reactions from
11、 mild to severe in sensitized individuals. NRL gloves shall meet the dimensional, physical, and quality requirements shown in Table I when tested according to Section 6.5 through 6.7. In addition, NRL gloves shall have no more than 200 ug/dm2extractable protein when tested according to Section 6.4.
12、5.4 Nitrile gloves Nitrile gloves are made of a synthetic material (carboxylated butadiene acrylonitrile copolymer). Nitrile is a thin, soft, elastic material with superior resistance to punctures, abrasion, and breakdown from animal fats. The gloves are very form-fitting with high tactile sensitivi
13、ty. Nitrile gloves shall meet the dimensional, physical, and quality requirements shown in Table I when tested according to Section 6.5 through 6.7. 5.5 Other glove materials Materials that are not covered under the scope of polyethylene, vinyl, natural rubber latex, or nitrile, may be proposed for
14、qualification to this protocol. Quality control data documenting dimensional stability, physical properties, and barrier integrity shall be provided prior to revision of the protocol to include additional material types. Revisions shall be reviewed by the NSF Expert Panel responsible for oversight o
15、f this protocol. NSF P155 6 2005 NSF TABLE I PERFORMANCE REQUIREMENTS SUMMARY Physical Dimension Physical Property Bioburden, Powder, Protein Content, Visible Defects Barrier Integrity Minimum Tensile Strength Minimum % Elongation Material Size Minimum Length (mm) Width Range (mm) Minimum Thickness
16、(mm) Max AQLa Before aging at plant After agingcBefore aging at plant After agingcMax AQLa Criteria Max AQLa LDPE XS S M L XL 250 250 260 265 265 95-135 100-145 105-155 110-165 120-170 0.0185 4 280 N/mb 280 N/mb 500 500 4 No failures 2.5 CPE XS S M L XL 285 285 300 300 300 100-135 100-145 115-155 13
17、0-165 135-170 0.024 4 360 N/mb 360 N/mb 300 300 4 No failures 2.5 HDPE XS S M L XL 210 210 210 210 210 125-160 135-170 145-180 155-190 165-200 0.016 4 320N/mb 320 N/mb 500 500 4 No failures 2.5 Vinyl PVC and Synthetic Vinyl Blends ASTM D5250 XS S M L XL 230 230 230 230 230 70-80 80-90 90-100 100-110
18、 110-120 0.05 4 9 MPa 9 MPa 300 300 4 No failures 2.5 Natural rubber latex ASTM D3578 XS S M L XL 220 220 230 230 230 60-80 70-90 85-105 91-121 110-130 0.08 4 14 MPa 14 MPa 700 500 4 No failures 2.5 Nitrile ASTM D6319 XS S M L XL 220 220 230 230 230 60-80 70-90 85-105 91-121 110-130 0.05 4 12.5 MPa
19、12.5 MPa 500 400 4 No failures 2.5 aAQL = Acceptable Quality Level bStrength measured in transverse direction and represented as N/m due to embossed surface cAfter accelerated aging at plant or after shipment NSF P155 7 2005 NSF 6 Test Methods 6.1 Materials Complete formulation information and a des
20、cription of the manufacturing process shall be submitted to NSF for review, including the following: Model name Material supplier Overall material name (i.e. natural rubber latex, PVC) Formulation identification List of ingredient suppliers Complete ingredient list and CAS numbers Percent by weight
21、of each ingredient in formulation Regulatory reference for each ingredient (CFR, WrC) 6.2 Glove powder 6.2.1 Initial qualification Samples for initial qualification shall be selected randomly from three separate lots (5 samples per lot = 15 total samples). Testing shall be conducted according to AST
22、M D6124. 6.2.2 Ongoing quality assurance Five samples for ongoing quality assurance shall be randomly selected from production lot(s) on a periodic basis for analysis. Testing shall be conducted according to ASTM D6124. NSF shall either perform the testing or verify the methodology and quality contr
23、ol practices of the manufacturing or contract laboratory. 6.3 Bioburden 6.3.1 Initial qualification Samples for initial qualification shall be randomly selected from three different production lots (3 samples per lot = 9 total samples). Testing shall be conducted according to ANSI/AAMI/ISO 11737-1,
24、as specified in Section 6.3.3. Ten percent of the gloves from each sample box, no greater than 10 and no less than 5 will be batch tested. 6.3.2 Ongoing quality assurance Three samples for ongoing quality assurance shall be randomly selected from production lot(s) on a periodic basis for analysis. T
25、esting shall be conducted according Section 6.3.3. NSF shall either perform the testing or verify the methodology and quality control practices of the manufacturing or contract laboratory. NSF P155 8 2005 NSF 6.3.3 Test method specifics This method is derived from ANSI/AAMI/ISO 11737-1. The approxim
26、ate external surface area shall be calculated for each glove type. Ten percent of the gloves from each sample box, no greater than 10 and no less than 5, shall be placed into a large sterile stomacher bag. A volume of 50 mL sterile eluting solution (sterile deionized water plus 1% Tween 80) shall be
27、 aseptically added to the bag. Gloves shall be agitated in the stomacher bag for 2 minutes to extract the organisms from the glove surfaces. The 50 mL extract shall be transferred into a sterile 250 mL bottle and stored at 4oC. A fresh 50 mL sterile elution buffer shall be added to the same stomache
28、r bag and the process is repeated four additional times, combining the eluents in the same 250 mL bottle for each event. To assess the total microbial and fungal load, serial ten-fold dilutions shall be made with the sample eluents. Dilutions shall be pour-plated with Standard Plate Count agar (Difc
29、o #DF0479-17-3) and spread-plated with Potato Dextrose agar (Difco #DF0013-17-6) for enumeration of bacteria and fungi, respectively. All plating shall be performed in triplicate. Escherichia coli (ATCC 11229) and Saccharomyces cerevisae (ATCC 18824) shall be used for positive control for the Standa
30、rd Plate Count agar and Potato Dextrose agar, respectively. The counts (in colony-forming-units per milliliter) for the triplicate plates of the five pooled elution events shall be averaged. The average cfu/mL shall be multiplied by the serial dilution factor and 250 mL, and divided by the number of
31、 gloves tested times the average surface area of the specific glove type. This cfu/cm2value shall be multiplied by 30 to obtain the final reporting units of cfu/30 cm2. Total bioburden count will be the combined value for the bacterial and fungal counts. 6.4 Extractable protein content (natural rubb
32、er latex gloves only) 6.4.1 Initial qualification Samples for initial qualification shall be randomly selected from three different production lots (3 samples per lot = 9 total samples). Samples shall be tested according to ASTM D5712. 6.4.2 Ongoing quality assurance Three samples for ongoing qualit
33、y assurance shall be randomly selected from production lot(s) on a periodic basis for analysis. Samples shall be tested according to ASTM D5712. NSF shall either perform the testing or verify the methodology and quality control practices of the manufacturing or contract laboratory. 6.5 Barrier integ
34、rity 6.5.1 Initial qualification Samples for initial qualification shall be randomly selected from three different production lots. Testing shall follow the requirements described in ANSI/ASQ Z1.4-1993 (ISO 2859) for Multiple Sampling at General Inspection Level I, Normal Inspection and Sample Size
35、Code Letter N (minimum of 125 samples per lot = 375 samples). Barrier integrity measurements shall be made according to the material type (see below): NSF P155 9 2005 NSF Latex, vinyl, and nitrile formulations: most recent edition of ASTM D5151 shall be used for barrier integrity testing. LDPE, CPE,
36、 and HDPE formulations: most recent edition of ASTM D5151 shall be used for barrier integrity testing of polyethylene formulations, with the following modifications: gloves shall be filled with a volume of water representing the hand contact area only. For longer gloves reaching over the wrist, wate
37、r shall be added to a level of 3 inches (7.6 cm) below the crotch between the thumb and index finger. For shorter gloves, water shall be added to the top of the cuff (see Figure 1 for details). NOTE: ASTM D5151 was developed for latex gloves with the assumption that the gloves are elastic and will s
38、tretch to accept the 1000 mL water volume. Polyethylene gloves do not stretch and filling the hand-area of the glove is all that is required to determine whether there are pinholes or holes in the seams. short polyethylene gloves long polyethylene gloves 3 ins. (7.6 cm) FILL LINEFigure 1. Barrier in
39、tegrity test for polyethylene gloves NSF P155 10 2005 NSF 6.5.2 Ongoing quality assurance Sampling and testing for ongoing quality assurance shall be conducted according to ANSI/ASQ Z1.4-1993 (ISO 2859) for Multiple Sampling at General Inspection Level I and Normal Inspection for the appropriate lot
40、 size. Samples shall be conditioned by accelerated aging as described in ASTM D573 prior to testing, if required. For polyethylene and vinyl gloves, aging conditions shall be according to specifications in ASTM D5250. For latex and nitrile gloves, aging conditions shall be according to specification
41、s in ASTM D3578 and D6319, respectively. Barrier integrity measurements shall be made according to the material type (see below): Latex, vinyl, and nitrile formulations: most recent edition of ASTM D5151 shall be used for barrier integrity testing. LDPE, CPE, and HDPE formulations: most recent editi
42、on of ASTM D5151 shall be used for barrier integrity testing of polyethylene formulations, with the following modifications: gloves shall be filled with a volume of water representing the hand contact area only. For longer gloves reaching over the wrist, water shall be added to a level of 3 inches (
43、7.6 cm) below the crotch between the thumb and index finger. For shorter gloves, water shall be added to the top of the cuff (see Figure 1 for details). 6.6 Dimensions 6.6.1 Initial qualification Samples for initial qualification shall be randomly selected from at least three different production lo
44、ts. Testing shall follow the requirements described in ANSI/ASQ Z1.4-1993 (ISO 2859) for Single Sampling Plan, Special Inspection Level S-2, Normal Inspection and Sample Size Code Letter E (13 samples per lot = 39 samples). Dimensions shall be measured according to ASTM D3767. See Figure 2 for locat
45、ion of thickness measurements for natural rubber latex, vinyl, and nitrile gloves. The center thickness measurement for polyethylene gloves shall be located at the center point of the width measurement. The width shall be measured at a level between the base of the index finger and the base of the t
46、humb. The length shall be measured from the tip of the middle finger to the outside edge of the cuff. 6.6.2 Ongoing quality assurance Sampling and testing for ongoing quality assurance shall be conducted according to ANSI/ASQ Z1.4-1993 (ISO 2859) for Single Sampling at Special Inspection Level S-2 a
47、nd Normal Inspection for the appropriate lot size. Samples shall be conditioned by accelerated aging as described in ASTM D573 prior to testing, if required. For polyethylene and vinyl gloves, aging conditions shall be according to specifications in ASTM D5250. For latex and nitrile gloves, aging co
48、nditions shall be according to specifications in ASTM D3578 and D6319, respectively. Dimensions shall be measured according to ASTM D3767 with thickness, width, and length locations as specified previously. NSF P155 11 2005 NSF Palm PositionFinger Tip Position48 9 mm33 5 mm13 3 mm Figure 2. Location
49、 of Thickness Measurements 6.7 Tensile properties 6.7.1 Initial qualification Samples for initial qualification shall be randomly selected from three different production lots. Testing shall follow the requirements described in ANSI/ASQ Z1.4-1993 (ISO 2859) for Single Sampling Plan, Special Inspection Level S-2, Normal Inspection and Sample Size Code Letter E (13 samples per lot = 39 samples). Tensile strength and elongation measurements shall be conducted according to the most recent edition of ASTM D882 “Standard Test Method for Tensil
