FDA 510(k)

용기 없는 니트릴 검사 장갑, 파란색, 화학 치료약 및 페ンタ니르 사이트레이트와 사용을 위해 검사됨

K-번호: K193555 · 2020-06-04

신청자Ever Global (Vietnam) Enterprise Corp

결정일2020-06-04

제품 코드LZC

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

결정대체적으로 동일

기기 요약

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate is the device name listed in this FDA 510(k) record. The listed applicant is Ever Global (Vietnam) Enterprise Corp. It received FDA 510(k) clearance on 2020-06-04 under 510(k) number K193555. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate?

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate is a medical device that received FDA 510(k) clearance on 2020-06-04. The listed applicant is Ever Global (Vietnam) Enterprise Corp. The 510(k) number is K193555.

When did Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate receive FDA 510(k) clearance?

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate received FDA 510(k) clearance on 2020-06-04, under 510(k) number K193555.

Who is the listed applicant for Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate?

The FDA 510(k) record lists Ever Global (Vietnam) Enterprise Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate?

The FDA product code for Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate is LZC.

Ever Global (Vietnam) Enterprise Corp를 신청인으로 등재한 기타 기록

K171422용기 없는 니트릴 검사 장갑, 흰색/파란색/검은색/분홍색 K170575용기 없는 투명/노른 실리콘 검진 장갑

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