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510(k) Data Aggregation
K Number
K070782Device Name
WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS HC-NB095F AND HC-NB295F
Manufacturer
Date Cleared
2007-04-11
(21 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
SURVIVAIR RESPIRATORS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Willson® ONE-Fit™ Flat-Fold™ Healthcare Particulate Respirator and Surgical Masks (HC-NB095F & HC-NB295F) are NIOSH-approved N95 single use respirators intended for use by healthcare personnel during medical/surgical procedures to protect both the wearer and the patient by protecting the wearer against the spatter of blood and other potentially infectious materials and reducing the transfer of microorganisms and other airborne particulate matter.
The Willson ONE-Fit Flat-Fold masks also meet the CDC guidelines for TB exposure control within healthcare facilities and are intended for use as an isolation mask.
Device Description
The Willson ONE-Fit Flat-Fold Healthcare Particulate Respirator and Surgical Masks are flat-fold style particulate respirator and surgical masks. The only difference between the two models is the number of straps; one has a single strap, the other a double strap.
The inner layer of the mask is constructed of spunbonded polypropylene, the middle layer is a filtration layer made of melt blown polypropylene and the outer layer is a covering of spunbonded polypropylene. The two halves that comprise the flat-fold facepiece are ultrasonically sealed together. The lower halves and is/are ultrasonically welded into the corners of the mask. The perimeter edges of the mask that contact the wearer's face are also ultrasonically sealed to provide reinforcement of the edges.
The Willson ONE-Fit Flat-Fold Healthcare Particulate Respirator and Surgical Masks are approved by NIOSH in accordance with 42 CFR 84 as N95 particulate respirators. NIOSH has issued approvals TC-84A-4372 (single strap) and TC-84A-4371 (dual strap).
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