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FDA 510(k)

mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed

Número K: K190876 · 2019-12-02

RequerenteMercator Medical (Thailand), Ltd.
Data da decisão2019-12-02
Código do produtoLZA
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed is the device name listed in this FDA 510(k) record. The listed applicant is Mercator Medical (Thailand), Ltd.. It received FDA 510(k) clearance on 2019-12-02 under 510(k) number K190876. 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 mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed?

mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed is a medical device that received FDA 510(k) clearance on 2019-12-02. The listed applicant is Mercator Medical (Thailand), Ltd.. The 510(k) number is K190876.

When did mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed receive FDA 510(k) clearance?

mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed received FDA 510(k) clearance on 2019-12-02, under 510(k) number K190876.

Who is the listed applicant for mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed?

The FDA 510(k) record lists Mercator Medical (Thailand), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed?

The FDA product code for mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed is LZA.

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Outros registros que listam Mercator Medical (Thailand), Ltd. como candidato(a)

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K251141Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl CitrateK213548Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with ChemotherapyK200967mCare(R) Powder Free Nitrile Orange Examination GlovesK192444mCare® Powder Free Nitrile Black Examination GloveK172930mCare Powder-free Blue Nitrile Examination Gloves

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.

Fonte oficial

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