FDA 510(k)

Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves

Numéro K : K211209 · 2021-12-17

Date de décision2021-12-17

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Hycare International Co., Ltd.. It received FDA 510(k) clearance on 2021-12-17 under 510(k) number K211209. 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 Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves?

Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-12-17. The listed applicant is Hycare International Co., Ltd.. The 510(k) number is K211209.

When did Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves receive FDA 510(k) clearance?

Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves received FDA 510(k) clearance on 2021-12-17, under 510(k) number K211209.

Who is the listed applicant for Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves?

The FDA 510(k) record lists Hycare International Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves?

The FDA product code for Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves is LZA.

Essais cliniques associés

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Dispositifs connexes (Code : LZA)

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Source officielle

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