FDA 510(k)

항암약물 치료와 사용을 위해 검증된 비스테라일 푸드리프리 블루 니트림 검사 장갑

K-번호: K172864 · 2018-05-02

결정일2018-05-02

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

Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Maxter Glove Manufacturing Sdn Bhd. It received FDA 510(k) clearance on 2018-05-02 under 510(k) number K172864. 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 Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs?

Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2018-05-02. The listed applicant is Maxter Glove Manufacturing Sdn Bhd. The 510(k) number is K172864.

When did Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs receive FDA 510(k) clearance?

Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs received FDA 510(k) clearance on 2018-05-02, under 510(k) number K172864.

Who is the listed applicant for Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs?

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

What is the FDA product code for Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs?

The FDA product code for Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is LZC.

Maxter Glove Manufacturing Sdn Bhd를 신청인으로 등재한 기타 기록

K151390무균 니트릴 검사 장갑 (화학 치료약물 사용 시 테스트 완료)

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