FDA 510(k)

빈알루미늄 검사 장갑 (투명, 비색상)

K-번호: K180849 · 2018-06-11

결정일2018-06-11

제품 코드LYZ

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

결정대체적으로 동일

기기 요약

Vinyl Examination Glove (Clear, Non-Colored) is the device name listed in this FDA 510(k) record. The listed applicant is Huifu Trading Co., Ltd.. It received FDA 510(k) clearance on 2018-06-11 under 510(k) number K180849. 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 Vinyl Examination Glove (Clear, Non-Colored)?

Vinyl Examination Glove (Clear, Non-Colored) is a medical device that received FDA 510(k) clearance on 2018-06-11. The listed applicant is Huifu Trading Co., Ltd.. The 510(k) number is K180849.

When did Vinyl Examination Glove (Clear, Non-Colored) receive FDA 510(k) clearance?

Vinyl Examination Glove (Clear, Non-Colored) received FDA 510(k) clearance on 2018-06-11, under 510(k) number K180849.

Who is the listed applicant for Vinyl Examination Glove (Clear, Non-Colored)?

The FDA 510(k) record lists Huifu Trading Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vinyl Examination Glove (Clear, Non-Colored)?

The FDA product code for Vinyl Examination Glove (Clear, Non-Colored) is LYZ.

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빈알루미늄 검사 장갑 (투명, 비색상)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LYZ)

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