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510(k) Data Aggregation
K Number
K222651Device Name
Surgical Face Mask
Manufacturer
Xiantao Sanda Industrial Co., Ltd
Date Cleared
2022-12-13
(103 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Xiantao Sanda Industrial Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Surgical Face Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
Device Description
The Surgical Face Masks are blue color, there-layer, flat-pleaded masks with nose piece and ear loops/ties, which are composed of outer layer, middle layer and inner layer. The outer layer and inner layer of the mask are made of polypropylene, the middle layer is made of melt-blown polypropylene. The ear loop/ties of the subject mask is held in place over the users' mouth and nose by two ear loops/ties welded to the face mask. The ear loop is made with polyester 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 high density polyethylene. The Surgical Face Mask is sold non-sterile and are intended to be single use, disposable devices. The mask is designed and manufactured in accordance with ASTM F2100 Standard Specification for Performance of Materials Used in Surgical Face Masks.
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K Number
K211462Device Name
Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask
Manufacturer
Xiantao S&J Protective Products Co., Ltd.
Date Cleared
2021-08-19
(100 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Xiantao S&J Protective Products Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Ear-loop Medical Face Mask/Disposable Tie-On Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face 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 device is a three-layers, flat-pleated mask. Its size is 17.5 cm x 9.5 cm, and it is available in two types, Ear-loop and Tie-On. Both the ear loop and tie-on masks are available in three barrier levels (Level 1, Level 3) based on ASTM F2100: 2019. The mask body is composed of three layers which is made of PP non-woven cloth. The difference between the three levels mask is the density of middle material. The ear loop or tie strings is used to secure the mask over the users' mouth and face. The nosepiece provides a firm fit over the nose. Ear loops are made of Nylon and spandex, and tie strings are made of PP non-woven cloth. The nose clip is made of Aluminum wire.
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