FDA 510(k)

Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White

K-번호: K190725 · 2019-12-17

결정일2019-12-17

제품 코드LZA

자문 위원회HO

결정Substantially Equivalent

기기 요약

Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White is the device name listed in this FDA 510(k) record. The listed applicant is Riverstone Resources Sdn Bhd. It received FDA 510(k) clearance on 2019-12-17 under 510(k) number K190725. 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 Glove Sterile Tested for use with Chemotherapy Drugs Claim, White?

Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White is a medical device that received FDA 510(k) clearance on 2019-12-17. The listed applicant is Riverstone Resources Sdn Bhd. The 510(k) number is K190725.

When did Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White receive FDA 510(k) clearance?

Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White received FDA 510(k) clearance on 2019-12-17, under 510(k) number K190725.

Who is the listed applicant for Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White?

The FDA 510(k) record lists Riverstone Resources Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White?

The FDA product code for Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White is LZA.

Riverstone Resources Sdn Bhd를 신청인으로 등재한 기타 기록

K220672블루 파우더 프리 니트릴 검사 장갑, 포도 향기, 화학요법 약물 및 페닌탈 테스트 주장 K220401Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim K200326Powder Free Nitrile Examination Glove (Aqua Green)K180452White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim

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