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510(k) Data Aggregation
K Number
K211827Device Name
Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)
Manufacturer
Zhejiang Lanhine Medical Products LTD
Date Cleared
2021-09-23
(101 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Zhejiang Lanhine Medical Products LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) are 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 a single use, disposable device(s), provided non-sterile.
Device Description
The proposed device (model: 15604F) is blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and it has Nose clips design for fitting the face mask around the nose.
The proposed device (model: 15704F) is blue color, and Flat Pleated type mask, utilizing tie-on way for wearing, and it has Nose clips design for fitting the face mask around the nose.
The proposed devices are manufactured with three layers, the inner and outer layers are made of Non-woven Fabric(polypropylene), and the middle layer is made of Melton brown Fabric (Polypropylene). The 15604F model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of polyurethane. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Polypropylene coating iron. The 15704F model of proposed device, tie-on, is held in place over the users' mouth and nose by two tie-on bands welded to the face mask. The tie-on bands are made of non-woven Fabric (Polypropylene). The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Polypropylene coating iron.
The proposed devices are sold non-sterile and are intended to be single use, disposable device.
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K Number
K211832Device Name
Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask
Manufacturer
Zhejiang Lanhine Medical Products LTD
Date Cleared
2021-09-08
(86 days)
Product Code
FXX, DAT
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Zhejiang Lanhine Medical Products LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fluid Resistant Procedure/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 face masks are intection 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 proposed device (model: 15603F) is blue color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and it has Nose clips design for fitting the face mask around the nose.
The proposed device (model: 15703F) is blue color, and Flat Pleated type mask, utilizing tie-on way for wearing, and it has Nose clips design for fitting the face mask around the nose.
The proposed devices are manufactured with three layers, the inner and outer layers are made of Non-woven Fabric(polypropylene), and the middle layer is made of Melton brown Fabric (Polypropylene). The 15603F model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of polyurethane. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Polypropylene coating iron. The 15703F model of proposed device, tie-on, is held in place over the users' mouth and nose by two tie-on bands welded to the face mask. The tie-on bands are made of non-woven Fabric (Polypropylene). The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Polypropylene coating iron. The proposed devices are sold non-sterile and are intended to be single use, disposable device.
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