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

Food and Drug Administration Philippines에 따르면, 해당 안전성 경고 는 Philippines 에서 N/A 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 연번
    2018-223
  • 사례 국가
  • 사례 출처
    FDAP
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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

  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    FDAP