FDA 510(k)

PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm

Numéro K : K151228 · 2016-01-15

Date de décision2016-01-15

Code produitKGO

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm is the device name listed in this FDA 510(k) record. The listed applicant is Emerson & Co. Srl. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K151228. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm?

PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Emerson & Co. Srl. The 510(k) number is K151228.

When did PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm receive FDA 510(k) clearance?

PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm received FDA 510(k) clearance on 2016-01-15, under 510(k) number K151228.

Who is the listed applicant for PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm?

The FDA 510(k) record lists Emerson & Co. Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm?

The FDA product code for PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm is KGO.

Essais cliniques associés

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Autres dossiers indiquant Emerson & Co. Srl en tant que demandeur

K192933Polyisoprene Powder Free, Black Colour Surgical Gloves

Dispositifs connexes (Code : KGO)

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Source officielle

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