FDA 510(k)

무균, 무분말, 파란 니트림 검사 장갑, 화학요법약 및 페ンタ니르와 사용 시험 통과

K-번호: K233520 · 2024-01-12

신청자Anhui Powerguard Technology Co., Ltd.

결정일2024-01-12

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

Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Powerguard Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-01-12 under 510(k) number K233520. 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 Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl?

Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is Anhui Powerguard Technology Co., Ltd.. The 510(k) number is K233520.

When did Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl receive FDA 510(k) clearance?

Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl received FDA 510(k) clearance on 2024-01-12, under 510(k) number K233520.

Who is the listed applicant for Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl?

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

What is the FDA product code for Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl?

The FDA product code for Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl is LZA.

Anhui Powerguard Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K211860무균 니트림 환자 검사 장갑, 파란색 K191292무균 비닐 환자 검사 장갑, 투명(색 없음)

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