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510(k) Data Aggregation
K Number
K230395Device Name
Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)
Manufacturer
Date Cleared
2023-07-17
(153 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
DURIO PPE SDN BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is intended for 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 Durio Surgical Face Mask is a non-sterile, single use, flat-pleated style surgical mask with ear loops and nose piece. The Durio Surgical Face Mask is available in three or four ply models. In all cases, the inner and outer layers of the Durio Surgical Face Mask are made of non-woven spunbond polypropylene (PP). The outer layer repels fluid and droplets. The middle layer is made of non-woven melt blown PP fabric for filtration by mechanical blocking and electrostatic attraction. For the four-ply model, there is an additional middle layer made of non-woven spunbound PP. The ear loops are made of polyester covered spandex yarn. The elastic ear loops pull inward from welding on the outer layer to reduce gaps as the side between the face and mask. The nose strip is made of zinc electro galvanized steel wire allowing adjustability and to let it stand fixed for better fit. The Durio Surgical Face Mask is provided in blue. The device is not made from any natural rubber latex.
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