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510(k) Data Aggregation
K Number
K231618Device Name
3 Layer Surgical Mask (134252531)
Manufacturer
Date Cleared
2023-07-28
(56 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Original Mattress Factory Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
When properly worn, the 3 Layer Surgical Masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.
Device Description
Subject Device (3 Layer Surgical Mask) is single use, 3 layers, flat-pleated style face mask with ear loops and moldable nose piece. The outer layer and inner facing layer of face mask consist of spun-bond polypropylene, and the middle layer consists of melt blown polypropylene filter. Each mask contains polyester / spandex blend ear loops to secure the mask over the user's face and mouth with moldable nose piece to firmly fit over the nose.
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