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510(k) Data Aggregation
K Number
K200576Device Name
ClearMask Transparent Surgical Face Mask
Manufacturer
Date Cleared
2020-04-06
(32 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
ClearMask, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ClearMask Transparent Surgical Face Mask is intended for use in healthcare settings, such as in operating rooms, or in other medical procedures such as dental, isolation and veterinary procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device allows for full view of the face and facial expressions, particularly the nose and mouth areas.
The device is indicated for over-the-counter use. The device is disposable and is indicated for single use. The device is not provided sterile.
Device Description
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