FDA 510(k)

니트림 검사 장갑, 장신구 확장형, 화학 치료약, 페닌시르트릿, 그리고 선택된 다른 약물과 사용을 위해 검증됨

K-번호: K230662 · 2023-10-26

신청자Zhonghong Pulin Medical Products Co., Ltd.

결정일2023-10-26

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 Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs is the device name listed in this FDA 510(k) record. The listed applicant is Zhonghong Pulin Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2023-10-26 under 510(k) number K230662. 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 Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs?

Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs is a medical device that received FDA 510(k) clearance on 2023-10-26. The listed applicant is Zhonghong Pulin Medical Products Co., Ltd.. The 510(k) number is K230662.

When did Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs receive FDA 510(k) clearance?

Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs received FDA 510(k) clearance on 2023-10-26, under 510(k) number K230662.

Who is the listed applicant for Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs?

The FDA 510(k) record lists Zhonghong Pulin Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs?

The FDA product code for Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs is LZA.

Zhonghong Pulin Medical Products Co., Ltd.를 신청인으로 등재한 기타 기록

K231029니트림 검사 장갑, 화학요법 약물 및 페닐페닐네타인과 사용을 위해 검증됨 K210460니트리텍 비닐 장갑 파우더 프리 블루 K171873무균 Nitrile 환자 검사 장갑, 파란색, 비 무균, 화학 치료약물 사용 시 테스트된 Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs K152712니트림 파우더 프리 환자 검사 장갑, 블루 색상

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