Search Results
Found 1 results
510(k) Data Aggregation
K Number
K212398Device Name
Surgical Face Mask (Non-sterile)
Manufacturer
Hubei Kimsoul Industrial Co., Ltd
Date Cleared
2021-12-15
(135 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Hubei Kimsoul Industrial Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 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 adult use 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 proposed device is a three-layer, flat pleated mask. Each mask is composed of a mask body, a nose piece and two ear loops. The mask body is manufactured with three layers, the inner layer and the outer layer are made of polypropylene spunbond nonwoven fabric, and the middle layer is made of polypropylene meltblown nonwoven fabric. It is held in place over the user's mouth and nose by two elastic ear loops welded to the mask body. The elastic ear loops are made of polyester and polyurethane, not made from natural rubber latex. The nose piece is in the layers of face mask to allow the user to fit the face mask around his nose, which is made of polyethylene.
The proposed device is provided non-sterile and is intended to be a single use, disposable device.
Ask a Question
Page 1 of 1