FDA 510(k)

용기성 비닐 검사 장갑

K-번호: K220469 · 2022-06-16

신청자Chifeng Huawei Medical Science&Technology Co., Ltd.

결정일2022-06-16

제품 코드LYZ

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

결정Substantially Equivalent

기기 요약

Disposable Vinyl Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Chifeng Huawei Medical Science&Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-06-16 under 510(k) number K220469. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Disposable Vinyl Examination Glove?

Disposable Vinyl Examination Glove is a medical device that received FDA 510(k) clearance on 2022-06-16. The listed applicant is Chifeng Huawei Medical Science&Technology Co., Ltd.. The 510(k) number is K220469.

When did Disposable Vinyl Examination Glove receive FDA 510(k) clearance?

Disposable Vinyl Examination Glove received FDA 510(k) clearance on 2022-06-16, under 510(k) number K220469.

Who is the listed applicant for Disposable Vinyl Examination Glove?

The FDA 510(k) record lists Chifeng Huawei Medical Science&Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Vinyl Examination Glove?

The FDA product code for Disposable Vinyl Examination Glove is LYZ.

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