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510(k) Data Aggregation
K Number
K203064Device Name
ICU Health Surgical Mask
Manufacturer
Date Cleared
2021-03-23
(165 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Plastikon Industries
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.
Device Description
The surgical mask is composed of three-layers and are flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, white), filter middle layer (polypropylene melt-blown, white) and inner layer (spunbond polypropylene, white). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.
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