FDA 510(k)

Vinyl Examination Glove (Clear, Non-Colored)

Numéro K : K180861 · 2018-06-13

Date de décision2018-06-13

Code produitLYZ

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Vinyl Examination Glove (Clear, Non-Colored) is the device name listed in this FDA 510(k) record. The listed applicant is Zhicheng Trading Co., Ltd.. It received FDA 510(k) clearance on 2018-06-13 under 510(k) number K180861. 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 Vinyl Examination Glove (Clear, Non-Colored)?

Vinyl Examination Glove (Clear, Non-Colored) is a medical device that received FDA 510(k) clearance on 2018-06-13. The listed applicant is Zhicheng Trading Co., Ltd.. The 510(k) number is K180861.

When did Vinyl Examination Glove (Clear, Non-Colored) receive FDA 510(k) clearance?

Vinyl Examination Glove (Clear, Non-Colored) received FDA 510(k) clearance on 2018-06-13, under 510(k) number K180861.

Who is the listed applicant for Vinyl Examination Glove (Clear, Non-Colored)?

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

What is the FDA product code for Vinyl Examination Glove (Clear, Non-Colored)?

The FDA product code for Vinyl Examination Glove (Clear, Non-Colored) is LYZ.

Essais cliniques associés

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Dispositifs connexes (Code : LYZ)

K260860Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)Basic Medical Technology, Inc.K252467Disposable Vinyl Examination GlovesViet Phu Trade and Import Export Co., Ltd.K252505Powder-Free Vinyl Exam Gloves, clearBasic Medical Technology, Inc.K241252Disposable Vinyl Examination GlovesAnqing Pukang Medical Technology Co., Ltd.K230046Vinyl examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221980Disposable Powder Free Vinyl Examination Gloves, Beige/ClearEver Global (Vietnam) Enterprise Corporation

Source officielle

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