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510(k) Data Aggregation
K Number
K212718Device Name
Surgical gowns
Manufacturer
Date Cleared
2022-01-12
(138 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Xiantao Dingcheng Non-Woven Product Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 material. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSU AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical gowns are single use, disposable medical devices, provided sterile.
Device Description
The Surgical gowns is composed of collar, body, sleeve and tie. The back is full opening, the neck and waist are laced, the sleeve are made of cotton closure by sewing, and the rest are made of heat sealing. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown.
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K Number
K212344Device Name
Surgical Mask
Manufacturer
Date Cleared
2021-11-16
(111 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Xiantao Dingcheng Non-woven Product Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non sterile.
Device Description
The Surgical Mask is single use, three-layer, flat-pleated style with ear straps and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Polypropylene+Galvanized-iron dual core. The Surgical Mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.
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