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510(k) Data Aggregation
K Number
K242502Device Name
Aurelia Surgical Mask ASTM Level-3 (2130)
Manufacturer
Supermax Healthcare Canada Supermax Medical
Date Cleared
2024-11-12
(82 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Supermax Healthcare Canada Supermax Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Aurelia Surgical Masks ASTM Level-3 (2130) is intended for use to minimize contamination caused by inhaled and exhaled microorganisms and reduce the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device and provided non-sterile
Device Description
The Aurelia Surgical Masks ASTM Level 3 are constructed with three layers of nonwoven polypropylene. The direct body contact materials include polypropylene, polyurethane, and nylon. The indirect body contacting materials include polypropylene and aluminum wire coated with melt-blown polypropylene embedded within the three layers.
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