FDA 510(k)

Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)

K-번호: K222449 · 2022-08-27

신청자Better Care Plastic Technology Co., Ltd.

결정일2022-08-27

제품 코드LZC

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

결정Substantially Equivalent

기기 요약

Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) is the device name listed in this FDA 510(k) record. The listed applicant is Better Care Plastic Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-08-27 under 510(k) number K222449. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)?

Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) is a medical device that received FDA 510(k) clearance on 2022-08-27. The listed applicant is Better Care Plastic Technology Co., Ltd.. The 510(k) number is K222449.

When did Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) receive FDA 510(k) clearance?

Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) received FDA 510(k) clearance on 2022-08-27, under 510(k) number K222449.

Who is the listed applicant for Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)?

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

What is the FDA product code for Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)?

The FDA product code for Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) is LZC.

Better Care Plastic Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K242533Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K232266Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K232070생분해 가능한 니트릴 검사 장갑 (블랙, 그린) - 화학 치료약 및 페ンタ니르 사이트레이트와의 사용을 위해 검증된 제품 K231567생분해성 니트림 포워드리스 검사 장갑, 화학요법 약물, 페ンタ니르 사이트레이트 및 선택된 다른 약물과 사용 시험 (파란색)K223713Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K221269Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

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