FDA 510(k)

Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less

Numéro K : K162175 · 2016-11-21

Date de décision2016-11-21

Code produitLYY

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less is the device name listed in this FDA 510(k) record. The listed applicant is Vietglove Corporation. It received FDA 510(k) clearance on 2016-11-21 under 510(k) number K162175. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less?

Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less is a medical device that received FDA 510(k) clearance on 2016-11-21. The listed applicant is Vietglove Corporation. The 510(k) number is K162175.

When did Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less receive FDA 510(k) clearance?

Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less received FDA 510(k) clearance on 2016-11-21, under 510(k) number K162175.

Who is the listed applicant for Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less?

The FDA 510(k) record lists Vietglove Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less?

The FDA product code for Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less is LYY.

Essais cliniques associés

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Autres dossiers indiquant Vietglove Corporation en tant que demandeur

K201428Powder Free Black Nitrile Examination Glove K170094POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED K153562Powder Free Blue Nitrile Examination Glove

Dispositifs connexes (Code : LYY)

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinComfort Rubber Gloves Industries Sdn. Bhd.K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company Limited K230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)Kossan International Sdn Bhd K223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd.K222612Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd.

Source officielle

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