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FDA 510(k)

Biodegradable Nitrile Examination Powder Free Glove, Green

K-Number: K192111 · 2020-09-03

ApplicantTop Glove Sdn. Bhd.
Decision Date2020-09-03
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Biodegradable Nitrile Examination Powder Free Glove, Green is a medical device manufactured by Top Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2020-09-03 under approval number K192111. 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 Biodegradable Nitrile Examination Powder Free Glove, Green?

Biodegradable Nitrile Examination Powder Free Glove, Green is a medical device that received FDA 510(k) clearance on 2020-09-03. It is manufactured by Top Glove Sdn. Bhd.. The 510(k) number is K192111.

When was Biodegradable Nitrile Examination Powder Free Glove, Green approved by the FDA?

Biodegradable Nitrile Examination Powder Free Glove, Green received FDA 510(k) clearance on 2020-09-03, under approval number K192111.

What company makes Biodegradable Nitrile Examination Powder Free Glove, Green?

Biodegradable Nitrile Examination Powder Free Glove, Green is manufactured by Top Glove Sdn. Bhd..

What is the FDA product code for Biodegradable Nitrile Examination Powder Free Glove, Green?

The FDA product code for Biodegradable Nitrile Examination Powder Free Glove, Green 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 Top Glove Sdn. Bhd.

K171279Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves K172923Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue K193150Latex Examination Powder Free Glove, Aloe Vera

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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