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510(k) Data Aggregation
K Number
K203528Device Name
KNH Surgical Face Mask
Manufacturer
Date Cleared
2022-11-16
(714 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
KNH Surgical Face Mask
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The KNH Surgical Face Mask is intended to protect both patient and healthcare workers from the transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only. Models: 1MMAB50DM2 (Level 1), 1MMAB50DM3 (Level 2)
Device Description
The KNH Surgical Face Masks are four-layer surgical masks that covers the user's nose and mouth and provides a physical barrier to fluids and particulate materials. This device is non-sterile and for single-use only. The mask is constructed of nonwoven fabric, including the outer cover web, insertion, filter web and the inner cover web, the mask is provided with ear loops and a nose wire for individualized fit. The models 1MMAB50DM2 and 1MMAB50DN3 differ in the thickness of the filter web layer.
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