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FDA 510(k)

BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free

K-Number: K213408 · 2022-04-17

ApplicantMeditech Gloves Sdn Bhd
Decision Date2022-04-17
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free is a medical device manufactured by Meditech Gloves Sdn Bhd. It received FDA 510(k) clearance on 2022-04-17 under approval number K213408. 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 BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free?

BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free is a medical device that received FDA 510(k) clearance on 2022-04-17. It is manufactured by Meditech Gloves Sdn Bhd. The 510(k) number is K213408.

When was BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free approved by the FDA?

BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free received FDA 510(k) clearance on 2022-04-17, under approval number K213408.

What company makes BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free?

BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free is manufactured by Meditech Gloves Sdn Bhd.

What is the FDA product code for BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free?

The FDA product code for BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free is LZA.

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Other Devices by Meditech Gloves Sdn Bhd

K210755Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue)

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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