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FDA 510(k)

Nitrile Medical Examination Gloves

Número K: K221108 · 2022-07-12

RequerenteAnhui Fulewei Electronic Technology Co.,Ltd
Data da decisão2022-07-12
Código do produtoLZA
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Nitrile Medical Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Fulewei Electronic Technology Co.,Ltd. It received FDA 510(k) clearance on 2022-07-12 under 510(k) number K221108. 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 Medical Examination Gloves?

Nitrile Medical Examination Gloves is a medical device that received FDA 510(k) clearance on 2022-07-12. The listed applicant is Anhui Fulewei Electronic Technology Co.,Ltd. The 510(k) number is K221108.

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

Nitrile Medical Examination Gloves received FDA 510(k) clearance on 2022-07-12, under 510(k) number K221108.

Who is the listed applicant for Nitrile Medical Examination Gloves?

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

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

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

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Dispositivos Relacionados (Código: LZA)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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 CitrateCardinalhealthK260794NON-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 BhdK262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

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