FDA 510(k)

무protein 레이블 주장 50ug/dm2 이하의 무분말 레이조우 검사 장갑

K-번호: K162175 · 2016-11-21

결정일2016-11-21

제품 코드LYY

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

결정대체적으로 동일

기기 요약

Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less is the device name listed in this FDA 510(k) record. The listed applicant is Vietglove Corporation. It received FDA 510(k) clearance on 2016-11-21 under 510(k) number K162175. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less?

Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less is a medical device that received FDA 510(k) clearance on 2016-11-21. The listed applicant is Vietglove Corporation. The 510(k) number is K162175.

When did Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less receive FDA 510(k) clearance?

Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less received FDA 510(k) clearance on 2016-11-21, under 510(k) number K162175.

Who is the listed applicant for Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less?

The FDA 510(k) record lists Vietglove Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less?

The FDA product code for Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less is LYY.

Vietglove Corporation를 신청인으로 등재한 기타 기록

K201428무균 검사용 블랙 니트림 장갑 K170094무가지 실리콘 검사 장갑, 포리머 코팅 K153562무균 블루 니트림 검사 장갑

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