FDA 510(k)

O'Star 니트림 검사 장갑 무분말

K-번호: K213058 · 2022-02-08

신청자Star Investment and Trade Joint Stock Company

결정일2022-02-08

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

O'Star Nitrile Examination Gloves Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Star Investment and Trade Joint Stock Company. It received FDA 510(k) clearance on 2022-02-08 under 510(k) number K213058. 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 O'Star Nitrile Examination Gloves Powder Free?

O'Star Nitrile Examination Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2022-02-08. The listed applicant is Star Investment and Trade Joint Stock Company. The 510(k) number is K213058.

When did O'Star Nitrile Examination Gloves Powder Free receive FDA 510(k) clearance?

O'Star Nitrile Examination Gloves Powder Free received FDA 510(k) clearance on 2022-02-08, under 510(k) number K213058.

Who is the listed applicant for O'Star Nitrile Examination Gloves Powder Free?

The FDA 510(k) record lists Star Investment and Trade Joint Stock Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for O'Star Nitrile Examination Gloves Powder Free?

The FDA product code for O'Star Nitrile Examination Gloves Powder Free is LZA.

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O'Star 니트림 검사 장갑 무분말

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LZA)

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