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FDA 510(k)

mCare® Powder Free Nitrile Black Examination Glove

K-Number: K192444 · 2019-12-31

ApplicantMercator Medical (Thailand), Ltd.
Decision Date2019-12-31
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

mCare® Powder Free Nitrile Black Examination Glove is a medical device manufactured by Mercator Medical (Thailand), Ltd.. It received FDA 510(k) clearance on 2019-12-31 under approval number K192444. 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 Nitrile Black Examination Glove?

mCare® Powder Free Nitrile Black Examination Glove is a medical device that received FDA 510(k) clearance on 2019-12-31. It is manufactured by Mercator Medical (Thailand), Ltd.. The 510(k) number is K192444.

When was mCare® Powder Free Nitrile Black Examination Glove approved by the FDA?

mCare® Powder Free Nitrile Black Examination Glove received FDA 510(k) clearance on 2019-12-31, under approval number K192444.

What company makes mCare® Powder Free Nitrile Black Examination Glove?

mCare® Powder Free Nitrile Black Examination Glove is manufactured by Mercator Medical (Thailand), Ltd..

What is the FDA product code for mCare® Powder Free Nitrile Black Examination Glove?

The FDA product code for mCare® Powder Free Nitrile Black Examination Glove is LZA.

Related Clinical Trials

NCT06968845 A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis RECRUITING NCT06849856 Evaluation of the Efficacy of Different Non-Surgical Peri-implantitis Treatment Approaches COMPLETED

Other Devices by Mercator Medical (Thailand), Ltd.

K172930mCare Powder-free Blue Nitrile Examination Gloves 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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