FDA 510(k)

Disposable Medical Synthetic Nitrile Examination Gloves

K-번호: K220354 · 2022-03-24

결정일2022-03-24

제품 코드LZA

자문 위원회HO

결정Substantially Equivalent

기기 요약

Disposable Medical Synthetic Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Niujian Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-03-24 under 510(k) number K220354. 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 Disposable Medical Synthetic Nitrile Examination Gloves?

Disposable Medical Synthetic Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2022-03-24. The listed applicant is Niujian Technology Co., Ltd.. The 510(k) number is K220354.

When did Disposable Medical Synthetic Nitrile Examination Gloves receive FDA 510(k) clearance?

Disposable Medical Synthetic Nitrile Examination Gloves received FDA 510(k) clearance on 2022-03-24, under 510(k) number K220354.

Who is the listed applicant for Disposable Medical Synthetic Nitrile Examination Gloves?

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

What is the FDA product code for Disposable Medical Synthetic Nitrile Examination Gloves?

The FDA product code for Disposable Medical Synthetic Nitrile Examination Gloves is LZA.

Niujian Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K220353Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs K210706Nitrile Examination Gloves

관련 기기 (코드: LZA)

K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealth K260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn Bhd K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.