FDA 510(k)

一次性ニトリル粉を含まない検査手袋

K番号: K213176 · 2021-12-13

申請者Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd.

決定日2021-12-13

製品コードLZA

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

Disposable Nitrile Powder-Free Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd.. It received FDA 510(k) clearance on 2021-12-13 under 510(k) number K213176. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Disposable Nitrile Powder-Free Examination Gloves?

Disposable Nitrile Powder-Free Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-12-13. The listed applicant is Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd.. The 510(k) number is K213176.

When did Disposable Nitrile Powder-Free Examination Gloves receive FDA 510(k) clearance?

Disposable Nitrile Powder-Free Examination Gloves received FDA 510(k) clearance on 2021-12-13, under 510(k) number K213176.

Who is the listed applicant for Disposable Nitrile Powder-Free Examination Gloves?

The FDA 510(k) record lists Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Nitrile Powder-Free Examination Gloves?

The FDA product code for Disposable Nitrile Powder-Free Examination Gloves is LZA.

申請者としてAnhui Zhong Lian Latex Gloves Manufacturing Co., Ltd.を記載するその他の記録

K220488disposable ニトリルポリフェニルフリーの検査手袋（化学療法薬との使用をテスト済み）

公式ソース

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