FDA 510(k)

センプーメッドシンテグラIR、無菌非粉体合成ゴム手術用手袋

K番号: K160781 · 2017-05-02

決定日2017-05-02

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

Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Semperit Investments Asia Pte , Ltd.. It received FDA 510(k) clearance on 2017-05-02 under 510(k) number K160781. 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 Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves?

Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves is a medical device that received FDA 510(k) clearance on 2017-05-02. The listed applicant is Semperit Investments Asia Pte , Ltd.. The 510(k) number is K160781.

When did Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves receive FDA 510(k) clearance?

Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves received FDA 510(k) clearance on 2017-05-02, under 510(k) number K160781.

Who is the listed applicant for Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves?

The FDA 510(k) record lists Semperit Investments Asia Pte , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves?

The FDA product code for Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves is KGO.

申請者としてSemperit Investments Asia Pte , Ltd.を記載するその他の記録

K223903非滅菌、単回使用、粉体不使用の検査手袋、青色、化学療法薬およびフェンタニルと使用を確認済みのもの小サイズ（NGPF102）；中サイズ（NGPF103）；大サイズ（NGPF104）；特大サイズ（NGPF105）K183441無粉体ニトリル患者検査手袋、緑色、非無菌、皮膚炎の可能性低、化学療法薬との使用試験済 K171378非無菌、単回使用、粉体不使用の検査手袋で、化学療法薬との使用を検証済み

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