FDA 510(k)

mCare Powder-free Blue Nitrile Examination Gloves

Numéro K : K172930 · 2018-04-13

DemandeurMercator Medical (Thailand), Ltd.

Date de décision2018-04-13

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

mCare Powder-free Blue Nitrile Examination Gloves 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 2018-04-13 under 510(k) number K172930. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the mCare Powder-free Blue Nitrile Examination Gloves?

mCare Powder-free Blue Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2018-04-13. The listed applicant is Mercator Medical (Thailand), Ltd.. The 510(k) number is K172930.

When did mCare Powder-free Blue Nitrile Examination Gloves receive FDA 510(k) clearance?

mCare Powder-free Blue Nitrile Examination Gloves received FDA 510(k) clearance on 2018-04-13, under 510(k) number K172930.

Who is the listed applicant for mCare Powder-free Blue Nitrile Examination Gloves?

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 Blue Nitrile Examination Gloves?

The FDA product code for mCare Powder-free Blue Nitrile Examination Gloves is LZA.

Essais cliniques associés

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Autres dossiers indiquant Mercator Medical (Thailand), Ltd. en tant que demandeur

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 Citrate K213548Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy K200967mCare(R) Powder Free Nitrile Orange Examination Gloves K192444mCare® Powder Free Nitrile Black Examination Glove K190876mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed

Dispositifs connexes (Code : 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.

Source officielle

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