FDA 510(k)

TMG Nitrile Powder Free Examination Glove

Numéro K : K213500 · 2022-02-21

Date de décision2022-02-21

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : LZA)

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Source officielle

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