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nitrile gloves 510k pdf template printable- nitrile gloves 510k pdf template word ,Cooperation partner. PREMIUM NITRILE EXAM Gloves- nitrile gloves 510k pdf template printable ,• Better chemical barriers than latex gloves • Eliminates exposure to latex PREMIUM NITRILE EXAM Gloves ... free nitrile, these gloves are ideal for jobs that require ...Manufactured in accordance to ASTM D6319-10 (2015), EN455: Part 1,2,3,4 , EU CE Regulation 2016/425, …WORLD GLOVES THAI2021-7-21 · MASK MANUFACTURER. Hight Quality Face Mask Ear-Loop 3PLY. Glove Manufacturer. Nitrile Powder Free. Latex - Sterile- Non-Sterile. Colors in Blue, Black, Pink, Green and Purple. Various Thickness: 3.5 mm – 5.0 mm. Glove Manufacturer. Nitrile Powder Free.



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Certificates – SeeDa Glove – Nitrile Glove, Latex Glove ... CE Certification for examination gloves EN455 Part 1-4, EN374 Part 1-5, EN420 ASTM D6319-10 / D6124-06 / D5151-19 / D6978-05 US FDA registration, FDA 510K TEC Type-Examination PPE EU Regulation 2016/425 Medical device directive 93/42 / EEC GMP / SVHC Thai FDA

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PPE VGlove - HIC- sterile nitrile gloves blue 510k form pdf ,MATERIAL: 100% Nitrile (Acrylonitirle - Butadiene), Latex free, Powder Free. FEATURES: Non-sterile, Ambidextrous, Fingertip Textured, Beaded Cuff, Gloves Used For Medical Examination, Free Of Protein. COLOR: Blue. PROLONGED TENSION BEFORE BREAKS: 14 - 18 mpa, 500% – 650% (before ...

Nitrile Gloves Documentation Meditech

2020-10-7 · 1. Nitrile Product Sheet with Picture 2. CE Marking 3. FDA Registration 4. FDA Certificate 5. EN 420 and EN 16523 6. EN 374-4 7. EN 455 1,2 & 3 8. EN 455 4 9. ASTM D 6319-4 Certificates 10.ISO 13485: 2016 Certificate 11.Declaration of Conformity 12.Manufacturing License 13.Carton on a Pallet Bird View 14.Image of Nitrile Gloves 15.Image of Box ...

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Socio colaborador. Multipurpose Nitrile Gloves - Inteplast Group- medical gloves fda 510k pdf fillable ,ASTM-D0412 FDA 510K AQL: 2.5 for pinholes for medical exam grade only ISO 9001:2000 Quality Standards Before Aging 14 (min) 500 (min) After Aging 14 (min) 400 (min) ASTM Standards Nitrile exam gloves shall comply with ASTM D3578 Standard Specifications …

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Cooperation partner. PREMIUM NITRILE EXAM Gloves- nitrile gloves 510k pdf template printable ,• Better chemical barriers than latex gloves • Eliminates exposure to latex PREMIUM NITRILE EXAM Gloves ... free nitrile, these gloves are ideal for jobs that require ...Manufactured in accordance to ASTM D6319-10 (2015), EN455: Part 1,2,3,4 , EU CE Regulation 2016/425, …

PRODUCT SPECIFICATION Nitrile Powder Free …

2020-8-13 · 1. 1 Type Nitrile Examination Glove, Powder Free, Online Single Non-sterileChlorinated, 1. 2 Material 100% Synthetic Nitrile Latex 1. 3 Color Blue 1. 4 Design and Feature Ambidextrous, finger textured, beaded cuff ... 1. 7 Shelf-Life The gloves shall have shelf life of 5 years from the date of manufacture with the above storage condition.

VGLOVE NITRILE GLOVES - PPE Group

2020-7-2 · POWDERED GLOVES PRODUCT INFORMATION VGLOVE Product Powdered Latex Examination Gloves Material Natural high grade latex Powder content ≤10 mg/d 2 Protein level Aqueous extractable protein : 200ug/g or less with label claim Color Natural Features Ambidextrous, beaded cuff, smooth or fully palm textured. Packing 100pcs/box, 10 boxes …

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fda 510(k) number submission date device name applicant; k913409: 07/30/1991: latex examination gloves: sdn. bhd. k122999: 09/27/2012: powder free nitrile examination gloves, tested for use with chemotherapy drugs: sdn. bhd. k990468: 02/16/1999: latex examination glove w/ low protein labeling: sdn. bhd. k021855: 06 ...

PRODUCT SPECIFICATION Nitrile Powder Free …

2020-8-13 · 1. 1 Type Nitrile Examination Glove, Powder Free, Online Single Non-sterileChlorinated, 1. 2 Material 100% Synthetic Nitrile Latex 1. 3 Color Blue 1. 4 Design and Feature Ambidextrous, finger textured, beaded cuff ... 1. 7 Shelf-Life The gloves shall have shelf life of 5 years from the date of manufacture with the above storage condition.

510(k) Summary Latex Examination Gloves Powder Free …

2010-8-5 · 510(k) Summary Latex Examination Gloves Powder Free 1.0 Submitter:JU1G20 Company Name: Riverstone Resources Sdn. Bhd. Company Address: Lot 55, 56, No. 15 Jalan Jasmin 2 Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung Selangor, Malaysia. Contact Person: Ms. Chong Chu Mee Telephone No: +603-60283033 Fax No: + 603-60283022

PPE-Aid Nitrile Gloves - Best Value Medical

2021-10-25 · PPE-Aid Nitrile Gloves. $ 4.95 – $ 45.00. Nitrile gloves are the perfect compromise between vinyl and latex. Nitrile is made from an allergy safe compound that feels a lot like latex but is much stronger and more …

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fda 510(k) number submission date device name applicant; k913409: 07/30/1991: latex examination gloves: sdn. bhd. k122999: 09/27/2012: powder free nitrile examination gloves, tested for use with chemotherapy drugs: sdn. bhd. k990468: 02/16/1999: latex examination glove w/ low protein labeling: sdn. bhd. k021855: 06 ...

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Socio colaborador. Standard Specification for Nitrile Examination Gloves for ...- vinyl gloves 510k pdf download pdf files ,7.7 Powdered Gloves: 7.7.1 Determine the recommended maximum powder limit using Test Method D6124 for powdered gloves. 7.7.2 Determine the square decimetres for the glove size as in the paragraph on determining the square decimetres of …

Kimberly-Clark Purple Nitrile Exam Gloves

2020-9-3 · Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves -12" Length Section 5 -510(k) Summary Preparation Date: February 14, 2012 Kimberly Clark Corporation Applicant: 1400 Holcomb Bridge Road Roswell, GA 30097 Contat Contat Peson:Lester Peson.Tel. F. Padilla No.: 678-352-6766

Nitrile Gloves – Global Gain Enterprises

VGLOVE NITRILE GLOVES. Vietnam Production of Natural rubber latex-free & powder-free gloves. The cuff is rolled for strength and the fingertips are textured for a better grip. Fingers & Pams: 0.05mm. Bracelet: 0.04 mm. CE, FDA & ISO 9001, ISO 13485, ISO 22000 certified. 100 gloves per box. 10 boxes per carton.

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Price per box of 100 gloves per box. Quantity in 1 Box - 100 Gloves = 50 pairs in 1 box; Thickness of gloves - 2.5mil; 2XL Nitrile gloves may come as 90 gloves/box or 100 gloves/box. No Return Policy - Please note that due necessary health and safety precautions, all PPE products including these Disposable Gloves are final sale. These items are ...

medical gloves fda 510k pdf template

Certificates – SeeDa Glove – Nitrile Glove, Latex Glove ... CE Certification for examination gloves EN455 Part 1-4, EN374 Part 1-5, EN420 ASTM D6319-10 / D6124-06 / D5151-19 / D6978-05 US FDA registration, FDA 510K TEC Type-Examination PPE EU Regulation 2016/425 Medical device directive 93/42 / EEC GMP / SVHC Thai FDA

PRODUCT SPECIFICATION Nitrile Powder Free …

2020-8-13 · 1. 1 Type Nitrile Examination Glove, Powder Free, Online Single Non-sterileChlorinated, 1. 2 Material 100% Synthetic Nitrile Latex 1. 3 Color Blue 1. 4 Design and Feature Ambidextrous, finger textured, beaded cuff ... 1. 7 Shelf-Life The gloves shall have shelf life of 5 years from the date of manufacture with the above storage condition.

Intco Basic SynGuard Nitrile Medical Examination Glove

2021-4-26 · FDA Registration & 510(k) Intco Basic SynGuard Nitrile Medical Examination Glove. ASTM D6319 Test Report Intco Basic SynGuard Nitrile Medical Examination Glove. ... Intco Basic SynGuard Nitrile Exam Gloves with Health Canada Approval ISO 9001:2015, ISO 13485:2016 and MDSAP Audit Certification.

Nitrile Gloves – Global Gain Enterprises

VGLOVE NITRILE GLOVES. Vietnam Production of Natural rubber latex-free & powder-free gloves. The cuff is rolled for strength and the fingertips are textured for a better grip. Fingers & Pams: 0.05mm. Bracelet: 0.04 mm. CE, FDA & ISO 9001, ISO 13485, ISO 22000 certified. 100 gloves per box. 10 boxes per carton.

medical gloves fda 510k pdf template

Certificates – SeeDa Glove – Nitrile Glove, Latex Glove ... CE Certification for examination gloves EN455 Part 1-4, EN374 Part 1-5, EN420 ASTM D6319-10 / D6124-06 / D5151-19 / D6978-05 US FDA registration, FDA 510K TEC Type-Examination PPE EU Regulation 2016/425 Medical device directive 93/42 / EEC GMP / SVHC Thai FDA

PRODUCT SPECIFICATION Nitrile Powder Free …

2020-8-13 · 1. 1 Type Nitrile Examination Glove, Powder Free, Online Single Non-sterileChlorinated, 1. 2 Material 100% Synthetic Nitrile Latex 1. 3 Color Blue 1. 4 Design and Feature Ambidextrous, finger textured, beaded cuff ... 1. 7 Shelf-Life The gloves shall have shelf life of 5 years from the date of manufacture with the above storage condition.

VGLOVE NITRILE GLOVES - PPE Group

2020-7-2 · POWDERED GLOVES PRODUCT INFORMATION VGLOVE Product Powdered Latex Examination Gloves Material Natural high grade latex Powder content ≤10 mg/d 2 Protein level Aqueous extractable protein : 200ug/g or less with label claim Color Natural Features Ambidextrous, beaded cuff, smooth or fully palm textured. Packing 100pcs/box, 10 boxes …

Kimberly-Clark Purple Nitrile Exam Gloves - Cleanroom …

2021-5-22 · KIMBERLY-CLARK* KC500 PURPLE NITRILE* Exam Gloves †D6319-00a Standard Specification for Nitrile Examnination Glove for Medical Applications ††Sterile PURPLE NITRILE-XTRA* = 305 mm†D6319-00a Standard Specification for Nitrile Examination Glove for Medical Applications TEST & TECHNICAL DATA Test Objective Relevance FDA Requirement (Eff. …