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510(k) Data Aggregation
K Number
K212366Device Name
Heartland Health Surgical Mask
Manufacturer
Date Cleared
2022-02-19
(204 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Heartland Health Products
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 the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.
Device Description
The surgical mask is a three-layer, flat pleated facepiece composed of a spunbond outer layer, filter layer, and spunbond (skin-contacting) inner layer. The mask is held in place with an elastic headband, and the position of the mask on the face is maintained with a nose wire and elastic beneath the chin. It is supplied non-sterile and is a single-use disposable.
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