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510(k) Data Aggregation
K Number
K231510Device Name
Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)
Manufacturer
Xiantao Zhibo Non-Woven Products Co., Ltd.
Date Cleared
2023-08-22
(89 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Xiantao Zhibo Non-Woven Products Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. This is a single use, disposable device, provided sterile.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Surgical Gown and Reinforced Surgical Gown met the requirements for Level 3 classification.
Device Description
The proposed device Surgical Gown its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The proposed device is available in S(110×130cm), M(120×140cm), L(130×150cm), XL(140×160cm), XXL(150×170cm), XXXL(155×180cm) sizes . This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.
The proposed device Reinforced Surgical Gown is its body, sleeve and belt are made of SMMS nonwoven material, and cuff is made of cotton. The reinforced and critical zone is front chest and sleeves. This zone is reinforced with PP/PE composite breathable film. The proposed device is available in S(110×130cm), M(120×140cm), L(130×150cm), XL(140×160cm), XXL(150×170cm), XXXL(155×180cm) sizes. This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.
The proposed devices are disposable medical devices and provided in sterile.
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