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Gloveon Paloma Nitrile Powder Free Examination Gloves FDA ...

Gloveon Paloma Nitrile Powder Free Examination Gloves FDA 510K (200pcs) (#1891), Origin: MalaysiaPowder-free, Chemo drug tested, ... Non-Sterile Rubber, Disposable Latex-Free Nitrile Exam Gloves - Medium Unit what's Nitrile Gloves…

510(k) Premarket Notification

Jan 25, 2021·Device Classification Name: surgeon's gloves: 510(k) Number: K171279: Device Name: Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves

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9 行·FDA 510k Review Fees (2020-2021) is $12432 (standard) and or $3108 (small Business) …

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CE Standard, EN 455 EN374-2, 510k FDA, ASTM D6319, ASTM3578 Standard Hi Risk Powder Free Non-sterile Gloves for Exam or Industrial uses Our Trademark Brand of Nitrile Gloves is the only Nitrile Gloves Produced and Certified Bacillus Census Free.

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Jun 15, 2020·The FDA does not intend to object to the distribution and use of surgeon’s gloves that …

FDA 510(k) Applications Submitted by KHAI HOAN JOINT STOCK ...

Searchable database of FDA 510(k) applications and descisions. FDA 510(k) Number Submission Date Device Name Applicant; K092681: 09/01/2009: POWDERED LATEX EXAMINATION GLOVES, NON-STERILE

March 2020 510(K) Clearances | FDA

March 2020 510(K) Clearances ... 30-MAR-20 Ivyland PA 18974 510(k) SUMMARY AVAILABLE …

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FDA 510k approval for Surgical Drapes - 🥇I3CGLOBAL

Aug 12, 2020·It is designed to provide privacy or a sterile operative field. In sterile areas, surgical drapes are mainly used to ensure that the surgical site is separated and isolated from other areas of the patient’s body. ... 510(k) exempt Enforcement discretion . Medical Device US FDA 510k Regulatory service, please read more >> ... US FDA 510k and ...

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510(k) Premarket Notification - accessdata.fda.gov

Jan 25, 2021·Device Classification Name: polymer patient examination glove: 510(k) Number: K132354: Device Name: POWDER FREE BLUDE NITRILE PATIENT EXAMINATION GLOVE, NON-STERILE

(Surgeon'S Gloves) - FDA 510(k) Applications Database

fda 510(k) number: applicant: device name: decision date: k893834: accurate medical devices, inc. accumed latex surgical glove: 12/14/1989: k892499: advance rubber, inc. safety surgeons gloves: 10/11/1989: k932061: advanced chemical technology, inc. miracle glove under the glove gloving cream: 11/16/1993: k891621: albors-menconi latex corp ...

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US FDA 510k and Registration for Gloves - I3CGLOBAL

Sep 21, 2020·US FDA 510k and Registration for Gloves. Published On - September 21, 2020. ... 510(k) Remarks . A surgeon’s glove is a disposable device made of natural rubber latex that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially ...

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Searchable database of FDA 510(k) applications and descisions. FDA 510(k) Number Submission Date Device Name Applicant; K092681: 09/01/2009: POWDERED LATEX EXAMINATION GLOVES, NON-STERILE

Nitrile Gloves 510K – International Consumer Corporation

Nitrile 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. Sizes S, M, L. Arrives 25 June.

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Nitrile Gloves - FDA 510K, CE-Class 3, ASTM-D-3578, ISO13485

Medical Nitrile Examination Gloves with FDA 410K, CE-Class 3, ASTM-D-3578, EC MARK FOR MEDICAL DEVICES UE 2017/745, and ISO13485.

510(k) Premarket Notification

Jan 25, 2021·Device Classification Name: polymer patient examination glove: 510(k) Number: K200539: Device Name: Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl

510(k) Premarket Notification

Jan 25, 2021·Device Classification Name: polymer patient examination glove: 510(k) Number: K200539: Device Name: Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with …

(Surgeon'S Gloves) - FDA 510(k) Applications Database

fda 510(k) number: applicant: device name: decision date: k893834: accurate medical devices, inc. accumed latex surgical glove: 12/14/1989: k892499: advance rubber, inc. safety surgeons gloves: 10/11/1989: k932061: advanced chemical technology, inc. miracle glove under the glove …

(Vinyl Patient Examination Glove) - FDA 510(k ...

Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient Examination Glove (Non-Sterile), 07/29/2015: K112741: LIFESTYLE SAFTY PRODUCTS (HUI ZHOU) CO. LTD: POWDER FREE VINYL PATIENT EXAMINATION GLOVE: 09/13/2012: K990946: LONG FIRST (XIAMEN) CO.,LTD. BROTHERS VINYL, POWDERED, PATIENT EXAMINATION GLOVES: 05/04/1999: K991085

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