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510(k) Data Aggregation
K Number
K230610Device Name
Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)
Manufacturer
Dongguan Shin Yi Healthcare Products Factory
Date Cleared
2023-08-23
(170 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Dongguan Shin Yi Healthcare Products Factory
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable Surgical Gown (Level 3, MF2103 Series)/ Disposable Surgical Gown (Level 3, MF2104 Series)/ Disposable Surgical Gown (Level 4, MF2105 Series) is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. It is single use, disposable and supplied sterile.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, MF2103 Series and MF2104 Series met the requirements for Level 3 classification, MF2105 Series met the requirements of Level 4 classification.
Device Description
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K Number
K210372Device Name
Disposable Surgical Mask
Manufacturer
Dongguan Shin Yi Healthcare Products Factory
Date Cleared
2021-06-07
(119 days)
Product Code
FXX, DAT
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Dongguan Shin Yi Healthcare Products Factory
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use ,disposable device, provided non-sterile.
Device Description
The proposed devices are single use, three-layer, flat masks with straps and nose piece. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The proposed device is held in place over the user's mouth and nose by two elastic ear loops or four ties welded to the face mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable aluminum wire. The proposed devices are sold non-sterile and are intended to be single use, disposable devices.
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