FDA 510(k)

니트릴 일회용 검사 장갑, 화학요법 약물 및 페ンタ니와의 사용을 위해 검증된 장갑 (D5000)

K-번호: K233990 · 2024-04-01

결정일2024-04-01

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

Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Xingyu Gloves Co., Ltd.. It received FDA 510(k) clearance on 2024-04-01 under 510(k) number K233990. 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 Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)?

Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) is a medical device that received FDA 510(k) clearance on 2024-04-01. The listed applicant is Shandong Xingyu Gloves Co., Ltd.. The 510(k) number is K233990.

When did Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) receive FDA 510(k) clearance?

Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) received FDA 510(k) clearance on 2024-04-01, under 510(k) number K233990.

Who is the listed applicant for Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)?

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

What is the FDA product code for Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)?

The FDA product code for Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) is LZA.

Shandong Xingyu Gloves Co., Ltd.를 신청인으로 등재한 기타 기록

K221272의료용 마스크 K171615싱유 니트림 파우더 프리 환자 검사 장갑, 흰색 K171616싱유 포워드리스 니트림 환자 검사 장갑, 블루 색상

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