Sure-Guard Disposable Vinyl Gloves and Sure-Guard Disposable Nitrile Gloves 의 안전성 경고

Safety alert

2018-223

Philippines

FDAP

https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/520417-fda-advisory-no-2018-223

Fda advisory no. 2018-223 lifting the advisory of sure-guard disposable vinyl gloves and sure-guard disposable nitrile gloves  under fda advisory no. 2018-121, subject “public health warning against the purchase and use of the unregistered medical device products (sure-guard disposable vinyl gloves and sure-guard disposable nitrile gloves)” the food and drug administration (fda) informs the public that the advisory on the products “sure-guard disposable vinyl gloves and sure-guard disposable nitrile gloves” under fda advisory no. 2018-121 dated 02 april 2018 is hereby lifted pursuant to the compliance of the market authorization holder to existing and applicable laws, rules, and regulations. the food and drug administration (fda) informs the public that the advisory on the products “sure-guard disposable vinyl gloves and sure-guard disposable nitrile gloves” under fda advisory no. 2018-121 dated 02 april 2018 is hereby lifted pursuant to the compliance of the market authorization holder to existing and applicable laws, rules, and regulations.  fda issued certificate of exemption for the above-mentioned products, the intended use of the said products distributed by amb hk enterprises inc is for industrial use.  the issuance of this advisory shall not in any manner preclude this office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to existing laws, rules, and regulations.  for more information and inquiries, please e-mail us at this email address is being protected from spambots. you need javascript enabled to view it. . attachments: fda advisory no. 2018-223.Pdf.