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 [email protected] or call the Center for Device Regulation, Radiation Health, and Research at (02) 857-1900 local 8301. To report sale or distribution of any unregistered medical device products, kindly email us via [email protected].