Decision Date2022-02-21
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
TMG Nitrile Powder Free Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Thai Medical Glove Co., Ltd.. It received FDA 510(k) clearance on 2022-02-21 under 510(k) 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. The listed applicant is Thai Medical Glove Co., Ltd.. The 510(k) number is K213500.
When did TMG Nitrile Powder Free Examination Glove receive FDA 510(k) clearance?
TMG Nitrile Powder Free Examination Glove received FDA 510(k) clearance on 2022-02-21, under 510(k) number K213500.
Who is the listed applicant for TMG Nitrile Powder Free Examination Glove?
The FDA 510(k) record lists Thai Medical Glove Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
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 Clinical Trials
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: LZA)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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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.