FDA 510(k)

手術衣（S、M、L、XL、XXL、XXXL）；強化手術衣（S、M、L、XL、XXL、XXXL）

K番号: K231510 · 2023-08-22

申請者Xiantao Zhibo Non-Woven Products Co., Ltd.

決定日2023-08-22

製品コードFYA

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

Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) is the device name listed in this FDA 510(k) record. The listed applicant is Xiantao Zhibo Non-Woven Products Co., Ltd.. It received FDA 510(k) clearance on 2023-08-22 under 510(k) number K231510. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)?

Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) is a medical device that received FDA 510(k) clearance on 2023-08-22. The listed applicant is Xiantao Zhibo Non-Woven Products Co., Ltd.. The 510(k) number is K231510.

When did Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) receive FDA 510(k) clearance?

Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) received FDA 510(k) clearance on 2023-08-22, under 510(k) number K231510.

Who is the listed applicant for Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)?

The FDA 510(k) record lists Xiantao Zhibo Non-Woven Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)?

The FDA product code for Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) is FYA.

申請者としてXiantao Zhibo Non-Woven Products Co., Ltd.を記載するその他の記録

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