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FDA 510(k)

Nitrile Powder Free Examination Gloves Biodegradable (Green)

K-Number: K240269 · 2024-10-25

ApplicantComfort Rubber Gloves Industries Sdn. Bhd.
Decision Date2024-10-25
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Powder Free Examination Gloves Biodegradable (Green) is a medical device manufactured by Comfort Rubber Gloves Industries Sdn. Bhd.. It received FDA 510(k) clearance on 2024-10-25 under approval number K240269. 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 Nitrile Powder Free Examination Gloves Biodegradable (Green)?

Nitrile Powder Free Examination Gloves Biodegradable (Green) is a medical device that received FDA 510(k) clearance on 2024-10-25. It is manufactured by Comfort Rubber Gloves Industries Sdn. Bhd.. The 510(k) number is K240269.

When was Nitrile Powder Free Examination Gloves Biodegradable (Green) approved by the FDA?

Nitrile Powder Free Examination Gloves Biodegradable (Green) received FDA 510(k) clearance on 2024-10-25, under approval number K240269.

What company makes Nitrile Powder Free Examination Gloves Biodegradable (Green)?

Nitrile Powder Free Examination Gloves Biodegradable (Green) is manufactured by Comfort Rubber Gloves Industries Sdn. Bhd..

What is the FDA product code for Nitrile Powder Free Examination Gloves Biodegradable (Green)?

The FDA product code for Nitrile Powder Free Examination Gloves Biodegradable (Green) is LZA.

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Other Devices by Comfort Rubber Gloves Industries Sdn. Bhd.

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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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