FDA 510(k)

PolyWear® 個人防護等級3袍子

K 號：K230384 · 2023-08-11

決定日期2023-08-11

產品代碼QPC

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

PolyWear® Personal Protective Level 3 Gown is the device name listed in this FDA 510(k) record. The listed applicant is PolyConversions, Inc.. It received FDA 510(k) clearance on 2023-08-11 under 510(k) number K230384. The device is classified under product code QPC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PolyWear® Personal Protective Level 3 Gown?

PolyWear® Personal Protective Level 3 Gown is a medical device that received FDA 510(k) clearance on 2023-08-11. The listed applicant is PolyConversions, Inc.. The 510(k) number is K230384.

When did PolyWear® Personal Protective Level 3 Gown receive FDA 510(k) clearance?

PolyWear® Personal Protective Level 3 Gown received FDA 510(k) clearance on 2023-08-11, under 510(k) number K230384.

Who is the listed applicant for PolyWear® Personal Protective Level 3 Gown?

FDA 510(k) 記錄將 PolyConversions, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for PolyWear® Personal Protective Level 3 Gown?

The FDA product code for PolyWear® Personal Protective Level 3 Gown is QPC.

其他以 PolyConversions, Inc. 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。

K261115VR®個人防護等級4袍子（VR袍子）K252940VR®個人防護等級3袍子（VR袍子）

相關器械（代碼：QPC）

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。

K262007PRIMED AAMI等級3開背袍PRIMED Medical Products, Inc.K261115VR®個人防護等級4袍子（VR袍子）PolyConversions, Inc.K252940VR®個人防護等級3袍子（VR袍子）PolyConversions, Inc.K242689AAMI 等級 4 保護；大褲Azac Group K233526美林開放式3級保護衣Medline Industries, LP K222128防護袍 AAMI第4級Kenpax International Limited

官方來源

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