Best N-DEX Free 7705PF and 7705PFT Gloves
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- Gertrude Stokes
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1 Best N-DEX Free 7705PF and 7705PFT Gloves Specifications and Compliance Information Best Manufacturing Company Features of Glove Patented accelerator free gloves 100% Nitrile non-latex laboratory glove No latex proteins No rubber accelerators Powder-free Proprietary non-allergenic polymer gel coating that aids in wet hand donning high visibility green color global sizing Textured fingertips (7705PFT) Smooth fingertips (7705PF) General Description of Best N-DEX Free 7705PF and 7705PFT Gloves: Best N-DEX Glove Style 7705PF and 7705PFT: N-DEX Free glove styles 7705PF and 7705PFT gloves are ambidextrous, 9.5 inches () in length, 4 mils thick disposable gloves made from 100% nitrile. Nitrile is a synthetic non-latex material named acrylonitrile butadiene copolymer. N-DEX Free 7705PF and 7705PFT gloves are completely powder-free. All N-DEX and N-DEX Free gloves feature the patented low modulus formulation that contains No Natural Rubber Proteins and delivers up to twice the puncture resistance of ordinary natural rubber latex or vinyl gloves. Note: N-DEX Free gloves are also available that meet the criteria for a Class Two Medical Exam glove and are also available that meet the NFPA 1999 Requirements for Emergency Medical Glove Use. Non-Allergenic Features of N-DEX Free Accelerator-Free Gloves: Non-Latex Gloves: Best N-DEX Free 7705PF and 7705PFT gloves, like all Best N-DEX 100% Nitrile gloves contain absolutely No Natural Rubber Proteins. Patented Accelerator Free Gloves: Because of the incidence of patients who were allergic to rubber accelerators used in Nitrile gloves, Best is the first company to develop and patent a process for making the world s first Accelerator-free Nitrile glove. Not only is the glove free from latex proteins which can cause life-threatening Type I Immediate Hypersensitivity reactions, N-DEX Free gloves are completely free of thiurams, carbamates and benzothiazoles which can cause Type IV Delayed Allergic Contact Dermatitis. N-DEX Free gloves are truly the most non-allergenic Nitrile gloves available. Page 1
2 Modified Draize Testing: All Best N-DEX Free glove styles passed the test for Hypoallergenicity. This test shows whether the level of rubber processing chemicals (accelerators, surfactants or antioxidants) would cause an allergic reaction in 200 human volunteers exposed to the gloves over time. This test was used in the past as the determining factor for hypoallergenicity claims before Latex allergy. The Modified Draize test is still a good indicator of chemical sensitivity but does not address protein sensitivity. The Modified Draize Test is nota good indicator of protein sensitivity. Since there are no latex proteins and no accelerators in N-DEX Free gloves, this test proves the non-allergenicity of N-DEX Free Accelerator-Free non-latex gloves. Compliance Information for Best N-DEX Free 7705 and 7705PFT Gloves: OSHA s Final Rule for Personal Protective Equipment: N-DEX Free 7705PF and 7705PFT gloves are recommended for many applications where PPE is required. Best Manufacturing Company can assist you in choosing the proper PPE by conducting an on-site hand and arm hazard assessment. Out trained experts will help you comply with the hand protection portion of OSHA s Final Rule on PPE in General Industry: Reference: 29 CFR Call for more information. Food and Pharmaceutical Use: N-DEX Free 7705PF and 7705PFT gloves are manufactured using only the materials and levels of materials that are listed in 21 CFR, parts 170 to 199. Best N-DEX gloves (all styles and sizes) are acceptable for use in both food and pharmaceutical applications. ASTM D Standard Specification for Nitrile Examination Gloves for Medical Application: Until this year the only exam glove standards were for natural rubber and vinyl gloves. The new Nitrile Exam Glove Standard includes performance of the gloves under conditions of stress, aging characteristics, sizing parameters, freedom from holes and sampling and inspection procedures. Although not considered Medical Devices, N-DEX Free 7705PF and 7705PFT gloves meet or exceed the performance requirements of this standard. ASTM D 5151 Test Method for Rubber-Detection of Holes in Medical Gloves: N-DEX Free 7705PF and 7705PFT gloves are tested to an Acceptable Quality Level (AQL) of 5 for freedom from holes. This AQL is more strict than what is required by ASTM for this new Nitrile Examination Glove Standard. This AQL also meets the requirements of the FDA in 21 CFR, part 800. Best uses air inflation testing as an alternative to the water leak testing. Features of all N-DEX Free Accelerator-Free Non-Latex Gloves: Material: N-DEX Free 7705PF and 7705PFT gloves are made of patented low modulus nitrile rubber. The US patent number is N-DEX 100% non-latex gloves are designed to relax and conform exactly to the hand within minutes of donning. This eliminates virtually all radial pressure on the hand. Higher modulus gloves cause more pressure that works against the hands natural movement and cause more perspiration. N-DEX Free gloves are made using a process that is also patented for accelerator-free technology. Donning Facilitator: N-DEX Free 7705PF and 7705PFT gloves feature a proprietary non-allergenic polymeric coating that aids in wet-hand donning of the gloves. Optimum Storage Conditions: The recommended storage conditions for N-DEX Free 7705PF and 7705PFT gloves is cool, dark and dry. N-DEX gloves do not deteriorate as quickly as natural rubber gloves and are not affected by ozone. Accelerated aging studies using ASTM D 573 indicate a shelf life of 5 years. Real time data, however, show that N-DEX gloves made more than 5 years ago showed acceptable tensile and modulus properties. Page 2
3 Physical Sizing of Best N-DEX Free 7705PF and 7705PFT Gloves Sizing Parameter X-Small (05-06) Small (06-07) Medium (07-08) Large (08-09) X-Large (09-10) Spec Range Weight per glove 5.1 g 5.3 g 5.7 g 7.0 g 7.25 g (+/- 0.5 g) Thickness (mils) 4.5 mil s 4.5 mil s 4.5 mil s 4.5 mil s 4.5 mil s (+/- 0.5 mils ) 3. Length of Glove inches mm (+/- 0.5 in.) (+/- 15 mm) 4. Palm Width inches mm 3.0 in. 75 mm 3.25 in. 85 mm 3.75 in 94 mm 4.0 in. 105 mm 4.5 in. 115 mm (+/- 0.5 in.) (+/- 15 mm) Polymer Characteristic Specificatio n ASTM Method Referenc e Tensile Strength > 2000 psi or 15 mpa ASTM D Modulus < 400 psi or 3 mpa ASTM D Ultimate Elongation > 500% ASTM D Puncture Resistance > 0.45 Kg ASTM F 1324 ASTM D 573: Physical Properties After Aging Physical Property Before Heat Agin g After Heat Agin g Tensile Strength > 2000 psi or 15 mpa >2400 psi or 15 mpa 2. Ultimate Elongation > 500% >400% Page 3
4 Electrostatic Data for N-DEX Gloves Test Method (Mil-B-81705C/EIA-541) Result s Static Decay 99% (+/- 5KV) 51 to 3.22 seconds 11 7 ohms/squar e Surface Resistivity.7 to 9.8 x10 3. Static Decay (NFPA 50% Relative Humidity) 0.7 seconds Ionic Extractable for N-DEX Gloves (Water) Element ug per glov e Elemen t ug per glov e Elemen t ug per glov e Barium Lithiu m < Silico n <70 Boron < 5 8. Magnesiu m < Sodium < 10K 3. Bromide ND 9. Nitrat e < 150 K 15. Sulfat e <1 K 4. Calcium < Phosphat e < Titaniu m < Chloride < 3 1 Phosphoru s < Zin c < Iron < 1 1 Potassiu m < 10 K Best Worldwide Contact Information United States: Best Manufacturing Company Edison Street Menlo, GA Phone: Fax: Europe: Best Manufacturing Europe NV Kontichsesteenweg 67/ Aartselaar Belgium Phone: Fax: Canada: Best Glove Manufacturing Ltd. 253 Michaud Street Coaticook, Quebec J1A1A9 Phone: Fax: Page 4
5 Chemical resistance testing has shown no statistically significant difference in the protection properties between N-DEX Free gloves and the Original N-DEX 7005 glove. The majority of this data was generated from testing of N-DEX 7005, but applies to Best N-DEX Free, as well. For heavy chemical exposure, we do not suggest disposable gloves, but rather chemical resistant gloves from our comprehensive chemical resistant glove product line. N-Dex Free 7705PF Gloves Total Immersion ASTM F 739 Total Immersion Chemical Tested Degradation (min) Permeation Breakthrough Rating MDL BDT RATE EN PPM Min. ug/cm2/min Rating 1. Acetaldehyde NR NR NR NR 0.02 NR NR 0 2. Acetic Acid 84% E P P NR 6.00 NR NR 0 3. Acetone NR NR NR NR 0.02 NR NR 0 4. Acetonitrile P P P P Acrylonitrile NR NR NR NR 0.02 NR NR 0 6. Ammonium Hydroxide 29% E E E E 0.08 ND ND 6 7. Amyl Acetate NR NR NR NR 0.02 NR NR 0 8. Amyl Alcohol E G G G Benzaldehyde NR NR NR NR 0.02 NR NR Benzene NR NR NR NR 0.02 NR NR Bromoacetophenone,2 (10% in Acetone) NT NT NT NT Butanol E E G G Butyl Acetate NR NR NR NR 0.02 NR NR P-Tert-Butyl Toluene NT NT NT NT Carbon Tetrachloride F NR NR NR 0.02 NR NR Cellosolve Acetate P NR NR NR 0.02 NR NR Chlorobenzene NR NR NR NR 0.02 NR NR Chloroform NR NR NR NR 0.02 NR NR Citric Acid E E E E --- ND ND Cresols P NR NR NR 0.02 NR NR Cyclohexane E E E E Cyclohexanol E E E G Cyclohexanone NR NR NR NR 0.02 NR NR n-dibutyl Phthalate G F P NR 0.02 NR NR o-dichlorobenzene NR NR NR NR 0.02 NR NR ,2-Dichloroethane NR NR NR NR 0.02 NR NR Diesel Fuel E E G G 0.02 ND ND Diethanolamine E E E E 0.02 ND ND Diethylamine P P P NR 0.02 NR NR Di-Isobutyl Ketone E E E E 0.02 NT NT NA 31. N,N-Dimethylacetamide NR NR NR NR 0.02 NR NR Dimethylformamide NR NR NR NR 0.02 NR NR Dimethylsulfoxide E G F P ,4-Dioxane NR NR NR NR 0.02 NR NR Ethanol E E E G Ethyl Acetate NR NR NR NR 0.02 NR NR Ethyl Benzene NR NR NR NR 0.02 NR NR Ethyl Ether G G G G Ethylene Glycol E E E E 0.02 ND ND Formaldehyde EPage E5 E E 8.00 ND ND 6
6 N-Dex Free 7705PF Gloves Total Immersion ASTM F 739 Total Immersion Chemical Tested Degradation (min) Permeation Breakthrough Rating MDL BDT RATE EN PPM Min. ug/cm2/min Rating 41. Formic Acid G NR NR NR 0.04 NR NR Furfural P NR NR NR 0.02 NR NR Gasoline E G P NR 0.02 NR NR Glutaraldehyde 50% E G G G 0.02 ND ND Glyphosate"RoundUp" E G G G 0.02 ND ND Heptane E E E E 0.02 NR NR Hexane E E E E Hydraulic Fluid E E E E N.A. NT NT NA 49. Hydrochloric Acid 37% E E E E 0.70 ND ND Iso Octane E E E G Isobutanol E F P P 0.02 NR NR Kerosene E E E E 0.02 NT NT NA 53. Lactic Acid 85% E E E E 0.04 ND ND Methanol E G G F 0.02 NR NR Methyl Ethyl Ketone NR NR NR NR 0.02 NR NR Methyl Isobutyl Ketone NR NR NR NR 0.02 NR NR Methyl Methacrylate NR NR NR NR 0.02 NR NR Methylamine 40% E E E G 0.02 NT NT NA 59. Methylene Chloride NR NR NR NR 0.02 NR NR N-Methylpyrrolidone NR NR NR NR 0.02 NR NR Methyl-Tert Butyl Ether G P P P 0.02 NR NR Mineral Spirits E E G F 0.02 NT NT NA 63. Monoethanolamine E E E E 0.04 ND ND Morpholine NR NR NR NR 0.02 NR NR Nitric Acid 70% G P NR NR 4.00 NR NR Nitrobenzene NR NR NR NR 0.02 NR NR Nitromethane F P P P 0.02 NR NR Nitropropane NR NR NR NR 0.02 NR NR n-octanol E E E G 0.02 ND ND Oleic Acid 98% E E E G --- ND ND Pentane E E E E Perchloroethylene F NR NR NR Petroleum Ether E E E E o-phosphoric Acid 85% E E E E ND ND Potassium Hydroxide 45% E E E E 0.40 ND ND Propanol E E E E n-propanol G F P P Propylene Oxide NR NR NR NR 0.02 NR NR Rotella Multigrade 15W40 Motor Oil E E E E 0.02 ND ND Shell Diala Oil AX Base Oil E E E E 0.02 ND ND Shell HVI 100 Neutral MQ Base Oil E E E E 0.02 ND ND Shell Turbo T 68 Hydraulic Oil E E E E 0.02 ND ND Shellwax 100 E E E E 0.02 ND ND Sodium Hydroxide 50% E E E E 0.02 ND ND Stoddard Solvent E E E E Sulfuric Acid 97% G P NR NR 0.05 NR NR Tannic Acid E E E E --- ND ND Tetrahydrofuran NR NR NR NR 0.02 NR NR Toluene NR NR NR NR 0.02 NR NR 0
7 N-Dex Free 7705PF Gloves Total Immersion ASTM F 739 Total Immersion Chemical Tested Degradation (min) Permeation Breakthrough Rating MDL BDT RATE EN PPM Min. ug/cm /min Rating 89. 1,2,4-Trichlorobenzene NR NR NR NR 0.02 NR NR ,1,1-Trichloroethane NR NR NR NR 0.02 NR NR Trichloroethylene NR NR NR NR 0.02 NR NR Tricresyl Phosphate E E G P 0.02 ND ND Triethanolamine E E E E 0.02 ND ND Turpentine E E E G 0.02 ND ND Xylene NR NR NR NR 0.02 NR NR 0 Degradation, Permeation Testing and CPC Rating of Best Gloves Degradation Degradation is a physical change in a glove after chemical exposure. Typical effects may be swelling, wrinkling, deterioration or delamination. There are no accepted standards for measuring degradation. Best degradation testing is based on a protocol considered by the ASTM F-23 Protective Clothing Committee. One side of the glove material is exposed to the test chemical for four hours. The percent weight change was measured gravimetrically at four time intervals: 5,30, 60, and 240 minutes. The ratings were assigned as follows: E = Excellent for a 0-10% weight change. G = Good for an 11-20% weight change. F = Fair for a 21-30% weight change. P = Poor for a 31-50% weight change. NR = Not Recommended for more than 50% weight change. N-DEX Degradation and Permeation Guide (Page # 5) Permeation Permeation: ASTM F test method for permeation of chemicals through chemical protective clothing under conditions of total immersion was followed. The units for reporting test results specified by ASTM F 739 include: Minimum Detection Limit (MDL in ppm): the smallest amount of chemical that is detectable using the analytical system that is being employed to measure the permeation of the chemical being tested. Breakthrough Detection Time (BDT): is the time in minutes after initial exposure of the glove to the test chemical to the time when the chemical is first detected on the inside of the glove. 3. Permeation Rate: is the steady state rate of a chemical in micrograms / minute permeating an area (cm2) of glove material. The units of ug/cm2/min are clearly specified by ASTM F 739 for reporting permeation rates at steady state. 4. Code used for reporting data: The code used for these test results is as follows: ND = No detectable breakthrough of chemical after eight hours of total immersion. NR = Not Recommended because of severe degradation. NA = Not applicable. NT = Not Tested. Blank spaces occur where test data is not yet completed. EN 374 Rating were devised by the European Normalization Committee and are ratings based on the breakthrough time in minutes where: Breakthough Time in Minutes Rating Less than 10 minutes minutes minutes minutes minutes 4 Greater than 240 minutes 5 Greater than 480 minutes 6
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