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FDA 510(k)

Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy

K-Number: K213548 · 2022-02-21

ApplicantMercator Medical (Thailand), Ltd.
Decision Date2022-02-21
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy is a medical device manufactured by Mercator Medical (Thailand), Ltd.. It received FDA 510(k) clearance on 2022-02-21 under approval number K213548. 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 Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy?

Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy is a medical device that received FDA 510(k) clearance on 2022-02-21. It is manufactured by Mercator Medical (Thailand), Ltd.. The 510(k) number is K213548.

When was Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy approved by the FDA?

Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy received FDA 510(k) clearance on 2022-02-21, under approval number K213548.

What company makes Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy?

Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy is manufactured by Mercator Medical (Thailand), Ltd..

What is the FDA product code for Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy?

The FDA product code for Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy is LZA.

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Related PubMed Literature

PMID: 41398461 Evaluating commercial multimodal AI for diabetic eye screening and implications for an alternative regulatory pathway. NPJ digital medicine (2025)

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 K200967mCare(R) Powder Free Nitrile Orange Examination Gloves 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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