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510(k) Data Aggregation
K Number
K212591Device Name
Disposable Surgical Gown
Manufacturer
Suzhou JaneE Medical Technology Co., Ltd
Date Cleared
2022-01-11
(148 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Suzhou JaneE Medical Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable 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. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). This is a single use, disposable device, provided sterile.
Device Description
The proposed device is a poly-reinforced surgical gown, the critical zone is front chest and sleeves. The critical zone is reinforced with PP/PE composite breathable film. The proposed device is available in four different sizes, include M, L, XL,TL. The proposed devices can meet the requirements for Level 3 per ANSVAAMI PB70:2012. The proposed devices are disposable medical devices and provided sterile.
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K Number
K212526Device Name
Surgical Face Mask
Manufacturer
Suzhou JaneE Medical Technology Co., Ltd.
Date Cleared
2021-11-09
(90 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Suzhou JaneE Medical Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Medical Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. They are 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 Disposable Medical Surgical Masks are green color, three-layer, flat-folded masks with nose piece and ear loops. The green colorant is polypropylene (PP) master batch.
The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The ear loops are held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loops are not made with natural rubber latex or fiberglass, but nylon and spandex.
The nose piece in the layers of face mask is to allow the user to fit the mask around their nose, which is made of Iron core coated with Polyethylene.
The Disposable Medical Surgical Masks are sold non-sterile and are intended to be single use, disposable devices.
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