FDA 510(k)

Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)

Número K: K213051 · 2021-12-18

RequerenteYunnan Huazhiyuan Medical Technology Co., Ltd.

Data da decisão2021-12-18

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) is the device name listed in this FDA 510(k) record. The listed applicant is Yunnan Huazhiyuan Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-12-18 under 510(k) number K213051. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)?

Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) is a medical device that received FDA 510(k) clearance on 2021-12-18. The listed applicant is Yunnan Huazhiyuan Medical Technology Co., Ltd.. The 510(k) number is K213051.

When did Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) receive FDA 510(k) clearance?

Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) received FDA 510(k) clearance on 2021-12-18, under 510(k) number K213051.

Who is the listed applicant for Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)?

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

What is the FDA product code for Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)?

The FDA product code for Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) is LZA.

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Outros registros que listam Yunnan Huazhiyuan Medical Technology Co., Ltd. como candidato(a)

K212002Synthetic Vinyl Examination Gloves K210686Nitrile Patient Examination Glove K210799Powder Free Vinyl Patient Examination Gloves

Dispositivos Relacionados (Código: 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.

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