FDA 510(k)

비정제, 파우더 프리 니트릴 검사 장갑 블랙 화학 치료약물 사용 시험

K-번호: K182241 · 2019-03-11

신청자Sri Trang Gloves (Thailand) Co., Ltd.

결정일2019-03-11

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

Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Sri Trang Gloves (Thailand) Co., Ltd.. It received FDA 510(k) clearance on 2019-03-11 under 510(k) number K182241. 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 Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs?

Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs is a medical device that received FDA 510(k) clearance on 2019-03-11. The listed applicant is Sri Trang Gloves (Thailand) Co., Ltd.. The 510(k) number is K182241.

When did Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs receive FDA 510(k) clearance?

Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs received FDA 510(k) clearance on 2019-03-11, under 510(k) number K182241.

Who is the listed applicant for Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs?

The FDA 510(k) record lists Sri Trang Gloves (Thailand) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs?

The FDA product code for Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs is LZA.

Sri Trang Gloves (Thailand) Co., Ltd.를 신청인으로 등재한 기타 기록

K182308비스테리올, 파우더 프리 니트림 검사 장갑 핑크 화학 치료약물 사용 시험

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