Decision Date2022-02-21
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
TMG Nitrile Powder Free Examination Glove is a medical device manufactured by Thai Medical Glove Co., Ltd.. It received FDA 510(k) clearance on 2022-02-21 under approval number K213500. 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 TMG Nitrile Powder Free Examination Glove?
TMG Nitrile Powder Free Examination Glove is a medical device that received FDA 510(k) clearance on 2022-02-21. It is manufactured by Thai Medical Glove Co., Ltd.. The 510(k) number is K213500.
When was TMG Nitrile Powder Free Examination Glove approved by the FDA?
TMG Nitrile Powder Free Examination Glove received FDA 510(k) clearance on 2022-02-21, under approval number K213500.
What company makes TMG Nitrile Powder Free Examination Glove?
TMG Nitrile Powder Free Examination Glove is manufactured by Thai Medical Glove Co., Ltd..
What is the FDA product code for TMG Nitrile Powder Free Examination Glove?
The FDA product code for TMG Nitrile Powder Free Examination Glove is LZA.
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.