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Bill of Lading, Container Number, Proof of Life, Specification and Certification Documents (FDA, CE, 510K, SGS if applicable). Complete the contact form to request for more information. We look forward to working with you!

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Bill of Lading, Container Number, Proof of Life, Specification and Certification Documents (FDA, CE, 510K, SGS if applicable). Complete the contact form to request for more information. We look forward to working with you!

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Nitrile Exam Gloves are a safe alternative to 'rubber or latex gloves' made from a synthetic gel, making them allergy free. Choose from sizes Small thru Extra-Large, nitrile exam gloves are FDA, ADA and OSHA approved, sold wholesale by the case.

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FDA 510 k Submission for Latex and Nitrile gloves (Surgical / Examination) A 510 k clearance is mandatory for examination and surgical gloves to market in the USA. FDA review time for a 510 k notification is 3 months, but in reality, it may take 6 months or more depends how perfect your 510k documentation is.

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Dimension Standard; Top Glove ASTM D6319 EN 455; Length (mm) Min 230, Min 240 or 300 +/- 10: Min 220 (XS, S) Min 230 (M, L, XL) Min 240 : Palm Width (mm) XS

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Device Classification Name: Patient Examination gloves (21 CFR 880.6250) Device Class: Class I Product Code: Latex -LYY 3.0 Identification of The Legally Marketed Device: Class I patient Examination gloves, Powder Free, LYY which meets all the requirement of ASTM D 3578-05 and FDA 21 CFR 880.6250. Section 2A- 1

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Description. FULL SCALE DISTRIBUTION LLC. MEDICAL NITRILE GLOVES. Material:Nitrile Certification: FDA,ce Powder Free, Textured,Latex Free Color:Black,white,blue

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