결정일2022-03-24
제품 코드LZA
자문 위원회HO
결정Substantially Equivalent
기기 요약
Black Nitrile Powder Free Patient Examination Glove, Non Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Rimba Glove Sdn Bhd. It received FDA 510(k) clearance on 2022-03-24 under 510(k) number K212916. 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 Black Nitrile Powder Free Patient Examination Glove, Non Sterile?
Black Nitrile Powder Free Patient Examination Glove, Non Sterile is a medical device that received FDA 510(k) clearance on 2022-03-24. The listed applicant is Rimba Glove Sdn Bhd. The 510(k) number is K212916.
When did Black Nitrile Powder Free Patient Examination Glove, Non Sterile receive FDA 510(k) clearance?
Black Nitrile Powder Free Patient Examination Glove, Non Sterile received FDA 510(k) clearance on 2022-03-24, under 510(k) number K212916.
Who is the listed applicant for Black Nitrile Powder Free Patient Examination Glove, Non Sterile?
The FDA 510(k) record lists Rimba Glove Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Black Nitrile Powder Free Patient Examination Glove, Non Sterile?
The FDA product code for Black Nitrile Powder Free Patient Examination Glove, Non Sterile is LZA.
관련 임상시험
관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.
관련 기기 (코드: LZA)
관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.
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공식 출처
FDA 데이터베이스에서 보기 →FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.