Events

Safety Alert for Sure-Guard Disposable Vinyl Gloves and Sure-Guard Disposable Nitrile Gloves

According to Food and Drug Administration Philippines, this safety alert involved a device in Philippines that was produced by N/A.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event Number
    2018-223
  • Event Country
    Philippines
  • Event Source
    FDAP
  • Event Source URL
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/520417-fda-advisory-no-2018-223
  • Notes / Alerts
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
  • Extra notes in the data
  • Reason
    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.

Device

Sure-Guard Disposable Vinyl Gloves and Sure-Guard Disposable Nitrile Gloves
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    FDAP