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FDA 510(k)

mCare(R) Powder Free Nitrile Orange Examination Gloves

K-Number: K200967 · 2020-06-06

ApplicantMercator Medical (Thailand), Ltd.
Decision Date2020-06-06
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

mCare(R) Powder Free Nitrile Orange Examination Gloves is a medical device manufactured by Mercator Medical (Thailand), Ltd.. It received FDA 510(k) clearance on 2020-06-06 under approval number K200967. 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(R) Powder Free Nitrile Orange Examination Gloves?

mCare(R) Powder Free Nitrile Orange Examination Gloves is a medical device that received FDA 510(k) clearance on 2020-06-06. It is manufactured by Mercator Medical (Thailand), Ltd.. The 510(k) number is K200967.

When was mCare(R) Powder Free Nitrile Orange Examination Gloves approved by the FDA?

mCare(R) Powder Free Nitrile Orange Examination Gloves received FDA 510(k) clearance on 2020-06-06, under approval number K200967.

What company makes mCare(R) Powder Free Nitrile Orange Examination Gloves?

mCare(R) Powder Free Nitrile Orange Examination Gloves is manufactured by Mercator Medical (Thailand), Ltd..

What is the FDA product code for mCare(R) Powder Free Nitrile Orange Examination Gloves?

The FDA product code for mCare(R) Powder Free Nitrile Orange Examination Gloves is LZA.

Related Clinical Trials

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Other Devices by Mercator Medical (Thailand), Ltd.

K172930mCare Powder-free Blue Nitrile Examination Gloves K192444mCare® Powder Free Nitrile Black Examination Glove K190876mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed 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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