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FDA 510(k)

mCare Powder-free Blue Nitrile Examination Gloves

K-Number: K172930 · 2018-04-13

ApplicantMercator Medical (Thailand), Ltd.
Decision Date2018-04-13
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

mCare Powder-free Blue Nitrile Examination Gloves is a medical device manufactured by Mercator Medical (Thailand), Ltd.. It received FDA 510(k) clearance on 2018-04-13 under approval number K172930. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Mercator Medical (Thailand), Ltd.. The 510(k) number is K172930.

When was mCare Powder-free Blue Nitrile Examination Gloves approved by the FDA?

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

What company makes mCare Powder-free Blue Nitrile Examination Gloves?

mCare Powder-free Blue Nitrile Examination Gloves is manufactured by Mercator Medical (Thailand), Ltd..

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.

Related Clinical Trials

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Other Devices by Mercator Medical (Thailand), Ltd.

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

Related Devices (Code: LZA)

K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy DrugsBrightway Holdings Sdn. Bhd. K161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove PinkTerang Nusa Sdn Bhd K161944Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsShandong Baisheng Medical Products Co., Ltd. K161074Powder Free Nitrile Examination Gloves Flock-Lined, Black ColorShen Wei (Usa), Inc. K162113Powder Free Nitrile Examination Gloves (Blue)Nam Viet Glove Joint Stock Company K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)Yty Industry (Manjung) Sdn Bhd

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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