FDA 510(k)

니트릴 검사 장갑 (화학 치료약물 사용 시 테스트됨)

K-번호: K242812 · 2024-10-12

결정일2024-10-12

제품 코드LZA

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

결정대체적으로 동일

기기 요약

NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) is the device name listed in this FDA 510(k) record. The listed applicant is Nb Medical Company Limited. It received FDA 510(k) clearance on 2024-10-12 under 510(k) number K242812. 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 EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs)?

NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2024-10-12. The listed applicant is Nb Medical Company Limited. The 510(k) number is K242812.

When did NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) receive FDA 510(k) clearance?

NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) received FDA 510(k) clearance on 2024-10-12, under 510(k) number K242812.

Who is the listed applicant for NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs)?

The FDA 510(k) record lists Nb Medical Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs)?

The FDA product code for NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) is LZA.

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니트릴 검사 장갑 (화학 치료약물 사용 시 테스트됨)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LZA)

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