FDA 510(k)

外科袍（S，M，L，XL，XXL，XXXL）；加強外科袍（S，M，L，XL，XXL，XXXL）

K 號：K231510 · 2023-08-22

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

決定日期2023-08-22

產品代碼FYA

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Xiantao Zhibo Non-Woven Products Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K182514外科口罩

相關器械（代碼：FYA）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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