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510(k) Data Aggregation
K Number
K202843Device Name
Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)
Manufacturer
B.J.ZH.F.Panther Medical Equipment Co., Ltd
Date Cleared
2021-01-12
(109 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
B.J.ZH.F.Panther Medical Equipment Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
Device Description
The proposed device, is a three-layer, single-use, flat-pleated mask. The inner and outer layers of the mask are made of spun-bonded nonwoven polypropylene, and the middle layer is made of melt-blown nonwoven polypropylene. The proposed devices are available in two types, ear-loop and Tie-on. The ear loops are made of nylon and spandex, and the ties are made of spun-bonded nonwoven polypropylene. The ear loops/tie-on is held in place over the users' mouth and nose by ear loops/ties welded to the mask. The nose clip is made of Medical polypropylene+Q235. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. Both the ear loop and tie-on masks are available in different sizes to provide more options for user. The proposed device can be provided in sterile and non-sterile two types.
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K Number
K202706Device Name
Surgical Gown (Sterile), Surgical Gown (Non-sterile)
Manufacturer
B.J.ZH.F.Panther Medical Equipment CO., LTD.
Date Cleared
2020-12-31
(106 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
B.J.ZH.F.Panther Medical Equipment CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Surgical gowns are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 3 classification.
Device Description
The proposed devices are 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. The proposed devices are single use, disposable medical devices and can be provided in sterile and non-sterile two types. Both the sterile and non-sterile surgical gowns are available in six sizes, including S, M, L, XL, XXL and XXXL. For non-sterile surgical gowns, they shall be sterilized by EO prior to use. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the proposed devices meet the requirements for Level 3 classification.
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