FDA 510(k)

PROGUARD ポリイソプレンポータルフリー、ブラック色手術手袋、モデル1: .22mm モデル2: .30mm

K番号: K151228 · 2016-01-15

決定日2016-01-15

製品コードKGO

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてEmerson & Co. Srlを記載するその他の記録

K192933ポリイソプレンポリフェアム、ブラックカラー手術用手袋

公式ソース

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