510(k) Premarket Notification | 合法醫療器材資訊網

7.0. Description of the Device: The Derma PreneO lsotouch* Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs, ... Read More

2017年12月29日 — We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device ... Read More

ANSELL HEALTHCARE PRODUCTS, INC. 1875 HARSH AVENUE, S.E.. massillon, OH 44646 -7199. Applicant Contact, james r chatterton. Correspondent ... Read More

2016年10月28日 — Ansell Healthcare Products LLC. Mr. Robert Mahler. Director, Regulatory Affairs for ... guide on the cuff edge label. Washing, drying and. Read More

EDGE 82-133 ... FDA Code of Federal Regulations, Title 21, Part 177, section 2600 (21 CFR 177.2600) - Rubber articles intended for repeated use. Read More

Active filter: Yes, in accordance with ASTM D6978 (Not listed in the US FDA 510k) Yes, in accordance with ASTM D6978 and US FDA cleared Remove all filters. Read More

Material. Natural Rubber Latex ( 1 ) Neoprene (Polychloroprene) ( 2 ) Nitrile ( 14 ) Vinyl (Polyvinyl Chloride) ( 1 ) · Brand. MICROFLEX® ( 9 ) EDGE® ( 3 ) Read More

2019年5月23日 — Ansell Healthcare Products, LLC. Don Cronk. Director, Regulatory Affairs for the Americas. 2301 Robb Drive. Reno, Nevada 89523. Re: K190018. Read More

Ansell Edge - Disposable Nitrile Gloves Made in Malaysia FDA 510k CE EN 455 EN 374 EN 420 ASTM D6319 ASTM D3767 .... #nitrilegloves #medicalgloves... Read More