FDA 510(k)

네프론 니트림 포워드리스 니트림 검사 장갑 (화학요법약물 사용 시 테스트됨)

K-번호: K223559 · 2023-02-09

결정일2023-02-09

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

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) is the device name listed in this FDA 510(k) record. The listed applicant is Nephron Pharmaceuticals Corporation. It received FDA 510(k) clearance on 2023-02-09 under 510(k) number K223559. 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 Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)?

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2023-02-09. The listed applicant is Nephron Pharmaceuticals Corporation. The 510(k) number is K223559.

When did Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) receive FDA 510(k) clearance?

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) received FDA 510(k) clearance on 2023-02-09, under 510(k) number K223559.

Who is the listed applicant for Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)?

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

What is the FDA product code for Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)?

The FDA product code for Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) is LZA.

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네프론 니트림 포워드리스 니트림 검사 장갑 (화학요법약물 사용 시 테스트됨)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LZA)

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