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FDA 510 k Submission for Latex and Nitrile gloves ...- intco nitrile gloves blue 510k form instructions ,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. FDA published guidance documents for latex and nitrile (examination and surgical) gloves 510k submission.Nitrile Gloves 510K – International Consumer CorporationNitrile Gloves 510K. SKU: 8-50018-92702-4 Category: Products. Description Additional information Reviews (0) Description. Made in Thailand. 4.7 mil thickness. Blue, with small quantity of green and purple color. 100 count boxes. 510K FDA medical certified.



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510(k) Number (if known) 1<141982 Device Name Form Approved: OMB No. 0910-0120 Expiration Date: January 31.2017 See PRA Statement on fast page. Dermagrip Powder Free Bluc Nitrile Patient Examination Gloves, Non-Steríle, Tested for use with Chemotherapy Drugs Indications for …

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BRAND / TYPE: Intco Medical Gloves AMOUNT: on request (from factory) STANDARDS: CE certificate, FDA 510(k) certificate, EN 420:2003+A1:2009, EN 455-1:2000, EN 455-2:2015, EN 455-3:2006, EN ISO 374-1:2016+A1:2018 Type B, EN 374-4:2013, EN ISO 374-5:2016, ISO 13485:2016, ISO 9001:2015 MATERIAL: nitrile / latex / vinyl / PVC MADE IN: China LOCATED IN: China PRICE: please contact …

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510(k) Number (if known) 1<141982 Device Name Form Approved: OMB No. 0910-0120 Expiration Date: January 31.2017 See PRA Statement on fast page. Dermagrip Powder Free Bluc Nitrile Patient Examination Gloves, Non-Steríle, Tested for use with Chemotherapy Drugs Indications for …

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Jun 21, 2021·510 (k) Number. K183354. Device Name. Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate. Applicant. GX Corporation SDN BHD. LOT 6491, Batu 5 3/4, Sementa, Jalan Kapar. klang, MY 42100. Applicant Contact.

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INTCO NITRILE GLOVES FEATURES Material Nitrile Type Medical Examination Sterile No Powder Free Yes Latex Free Yes Beaded Cuff Yes Ambidextrous Yes Colour Blue Outer Surface Finger Textured Length 230 mm Weight (M) 3.5g 0.2g Single Wall Yes Thickness - Palm 0.07 mm Thickness - Fingers 0.09 mm Sizes S / M / L / XL STANDARDS & ACCREDITATIONS FDA 510K ASTM D6319, …

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