FDA 510(k)

무균 블루 니트림 검사 장갑, 32가지 화학요법약 및 페닐피라진에 대한 사용 시험 완료

K-번호: K183354 · 2019-06-20

결정일2019-06-20

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

Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate is the device name listed in this FDA 510(k) record. The listed applicant is Gx Corporation Sdn Bhd. It received FDA 510(k) clearance on 2019-06-20 under 510(k) number K183354. 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 Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate?

Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate is a medical device that received FDA 510(k) clearance on 2019-06-20. The listed applicant is Gx Corporation Sdn Bhd. The 510(k) number is K183354.

When did Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate receive FDA 510(k) clearance?

Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate received FDA 510(k) clearance on 2019-06-20, under 510(k) number K183354.

Who is the listed applicant for Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate?

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

What is the FDA product code for Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate?

The FDA product code for Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate is LZA.

Gx Corporation Sdn Bhd를 신청인으로 등재한 기타 기록

K200915무균 흰색 폴리이소프놀렌 수술 장갑-화학 치료약물과 사용을 위해 검증된 장갑

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