FDA 510(k)

無菌ビニル検査手袋、粉無し

K番号: K170612 · 2017-10-23

決定日2017-10-23

製品コードLYZ

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

STERILE VINYL EXAMINATION GLOVES, Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Primus Gloves Pvt Limited. It received FDA 510(k) clearance on 2017-10-23 under 510(k) number K170612. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the STERILE VINYL EXAMINATION GLOVES, Powder Free?

STERILE VINYL EXAMINATION GLOVES, Powder Free is a medical device that received FDA 510(k) clearance on 2017-10-23. The listed applicant is Primus Gloves Pvt Limited. The 510(k) number is K170612.

When did STERILE VINYL EXAMINATION GLOVES, Powder Free receive FDA 510(k) clearance?

STERILE VINYL EXAMINATION GLOVES, Powder Free received FDA 510(k) clearance on 2017-10-23, under 510(k) number K170612.

Who is the listed applicant for STERILE VINYL EXAMINATION GLOVES, Powder Free?

The FDA 510(k) record lists Primus Gloves Pvt Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE VINYL EXAMINATION GLOVES, Powder Free?

The FDA product code for STERILE VINYL EXAMINATION GLOVES, Powder Free is LYZ.

申請者としてPrimus Gloves Pvt Limitedを記載するその他の記録

K170515無菌ニトリル手術手袋、粉体不使用 K143477ニトリル患者検査手袋、粉なし、青色

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。