FDA 510(k)

무균 니트림 검사 장갑 (파랑, 비올렛 블루, 흰색, 코발트 블루)

K-번호: K202356 · 2021-03-02

신청자Kanglongda Vietnam Protection Technology Company Limited

결정일2021-03-02

제품 코드LZA

자문 위원회의료장비 규제 텍스트 번역 HO [원문 텍스트가 제공되지 않았기 때문에 번역할 수 없습니다. 원문 텍스트를 제공해 주시면 번역을 도와드리겠습니다.]

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기기 요약

Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) is the device name listed in this FDA 510(k) record. The listed applicant is Kanglongda Vietnam Protection Technology Company Limited. It received FDA 510(k) clearance on 2021-03-02 under 510(k) number K202356. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)?

Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) is a medical device that received FDA 510(k) clearance on 2021-03-02. The listed applicant is Kanglongda Vietnam Protection Technology Company Limited. The 510(k) number is K202356.

When did Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) receive FDA 510(k) clearance?

Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) received FDA 510(k) clearance on 2021-03-02, under 510(k) number K202356.

Who is the listed applicant for Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)?

The FDA 510(k) record lists Kanglongda Vietnam Protection Technology Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)?

The FDA product code for Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) is LZA.

Kanglongda Vietnam Protection Technology Company Limited를 신청인으로 등재한 기타 기록

K253824무균 비스테로일 검사 장갑 무균 검사 장갑 K241970무균 니트림 검사 장갑 (파랑), 화학 치료약 및 페ンタ니르 사이트레이트와의 사용을 위해 검증됨 (XS, S, M, L, XL, XXL)

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