FDA 510(k)

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)

Numéro K : K182043 · 2018-09-21

DemandeurHebei Titans Hongsen Medical Technology Co., Ltd.

Date de décision2018-09-21

Code produitLYZ

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-09-21 under 510(k) number K182043. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)?

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) is a medical device that received FDA 510(k) clearance on 2018-09-21. The listed applicant is Hebei Titans Hongsen Medical Technology Co., Ltd.. The 510(k) number is K182043.

When did Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) receive FDA 510(k) clearance?

Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) received FDA 510(k) clearance on 2018-09-21, under 510(k) number K182043.

Who is the listed applicant for Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)?

The FDA 510(k) record lists Hebei Titans Hongsen Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)?

The FDA product code for Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) is LYZ.

Essais cliniques associés

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Source officielle

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