결정일2021-12-11
제품 코드LZA
자문 위원회HO
결정Substantially Equivalent
기기 요약
Nitrile Gloves (Model: NE01) is the device name listed in this FDA 510(k) record. The listed applicant is Byd Auto Industry Company Limited. It received FDA 510(k) clearance on 2021-12-11 under 510(k) number K212840. 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 Nitrile Gloves (Model: NE01)?
Nitrile Gloves (Model: NE01) is a medical device that received FDA 510(k) clearance on 2021-12-11. The listed applicant is Byd Auto Industry Company Limited. The 510(k) number is K212840.
When did Nitrile Gloves (Model: NE01) receive FDA 510(k) clearance?
Nitrile Gloves (Model: NE01) received FDA 510(k) clearance on 2021-12-11, under 510(k) number K212840.
Who is the listed applicant for Nitrile Gloves (Model: NE01)?
The FDA 510(k) record lists Byd Auto Industry Company Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Nitrile Gloves (Model: NE01)?
The FDA product code for Nitrile Gloves (Model: NE01) 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.