FDA 510(k)

無菌ラテックス手術手袋、粉体不使用

K番号: K171550 · 2018-07-13

決定日2018-07-13

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

Sterile Latex Surgical Gloves, Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Sanrea Healthcare Products Pvt, Ltd.. It received FDA 510(k) clearance on 2018-07-13 under 510(k) number K171550. 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 Sterile Latex Surgical Gloves, Powder Free?

Sterile Latex Surgical Gloves, Powder Free is a medical device that received FDA 510(k) clearance on 2018-07-13. The listed applicant is Sanrea Healthcare Products Pvt, Ltd.. The 510(k) number is K171550.

When did Sterile Latex Surgical Gloves, Powder Free receive FDA 510(k) clearance?

Sterile Latex Surgical Gloves, Powder Free received FDA 510(k) clearance on 2018-07-13, under 510(k) number K171550.

Who is the listed applicant for Sterile Latex Surgical Gloves, Powder Free?

The FDA 510(k) record lists Sanrea Healthcare Products Pvt, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Latex Surgical Gloves, Powder Free?

The FDA product code for Sterile Latex Surgical Gloves, Powder Free is KGO.

申請者としてSanrea Healthcare Products Pvt, Ltd.を記載するその他の記録

K171367SANCARE無菌ラテックス検査手袋（GLOVTEK無菌ラテックス検査手袋としても販売されています）K171093無菌ニトリル患者検査手袋、粉無し

公式ソース

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