FDA 510(k)

Synthetic Polymer Glove - Polyethylene (Black)

Numéro K : K222531 · 2023-01-22

Date de décision2023-01-22

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Synthetic Polymer Glove - Polyethylene (Black) is the device name listed in this FDA 510(k) record. The listed applicant is Ur Industry Sdn Bhd. It received FDA 510(k) clearance on 2023-01-22 under 510(k) number K222531. 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 Synthetic Polymer Glove - Polyethylene (Black)?

Synthetic Polymer Glove - Polyethylene (Black) is a medical device that received FDA 510(k) clearance on 2023-01-22. The listed applicant is Ur Industry Sdn Bhd. The 510(k) number is K222531.

When did Synthetic Polymer Glove - Polyethylene (Black) receive FDA 510(k) clearance?

Synthetic Polymer Glove - Polyethylene (Black) received FDA 510(k) clearance on 2023-01-22, under 510(k) number K222531.

Who is the listed applicant for Synthetic Polymer Glove - Polyethylene (Black)?

The FDA 510(k) record lists Ur Industry Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synthetic Polymer Glove - Polyethylene (Black)?

The FDA product code for Synthetic Polymer Glove - Polyethylene (Black) is LZA.

Essais cliniques associés

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Dispositifs connexes (Code : LZA)

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Source officielle

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