FDA 510(k)

メディスポレザーサービスグローブ、メディスポポリイソプレーンサービスグローブ

K番号: K203483 · 2021-02-01

決定日2021-02-01

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

Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Hbm Health Protections, Inc.. It received FDA 510(k) clearance on 2021-02-01 under 510(k) number K203483. 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 Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves?

Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves is a medical device that received FDA 510(k) clearance on 2021-02-01. The listed applicant is Guilin Hbm Health Protections, Inc.. The 510(k) number is K203483.

When did Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves receive FDA 510(k) clearance?

Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves received FDA 510(k) clearance on 2021-02-01, under 510(k) number K203483.

Who is the listed applicant for Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves?

The FDA 510(k) record lists Guilin Hbm Health Protections, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves?

The FDA product code for Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves is KGO.

申請者としてGuilin Hbm Health Protections, Inc.を記載するその他の記録

K221748メディスポレザーサービスグローブ、メディスポポリイソプレーンサービスグローブ

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