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FDA 510(k)

Powder Free Chloroprene Examination Glove Coloured (Blue, Green)

K-Number: K213993 · 2022-08-05

ApplicantCareglove Global Sdn. Bhd.
Decision Date2022-08-05
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Chloroprene Examination Glove Coloured (Blue, Green) is a medical device manufactured by Careglove Global Sdn. Bhd.. It received FDA 510(k) clearance on 2022-08-05 under approval number K213993. 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 Powder Free Chloroprene Examination Glove Coloured (Blue, Green)?

Powder Free Chloroprene Examination Glove Coloured (Blue, Green) is a medical device that received FDA 510(k) clearance on 2022-08-05. It is manufactured by Careglove Global Sdn. Bhd.. The 510(k) number is K213993.

When was Powder Free Chloroprene Examination Glove Coloured (Blue, Green) approved by the FDA?

Powder Free Chloroprene Examination Glove Coloured (Blue, Green) received FDA 510(k) clearance on 2022-08-05, under approval number K213993.

What company makes Powder Free Chloroprene Examination Glove Coloured (Blue, Green)?

Powder Free Chloroprene Examination Glove Coloured (Blue, Green) is manufactured by Careglove Global Sdn. Bhd..

What is the FDA product code for Powder Free Chloroprene Examination Glove Coloured (Blue, Green)?

The FDA product code for Powder Free Chloroprene Examination Glove Coloured (Blue, Green) is LZA.

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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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