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510(k) Data Aggregation
Device Name
KP Protective Face MaskManufacturer
Date Cleared
2025-12-22
(423 days)
Product Code
Regulation Number
878.4040Type
TraditionalPanel
General HospitalAge Range
All
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The KP Protective Face Mask is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Device Description
The KP Protective Face Mask is a non-sterile, single-use surgical mask intended to cover the user's nose and mouth, providing a physical barrier to fluids, microorganisms, and particulate matter.
The mask consists of three nonwoven polypropylene layers, including:
- Outer layer: Spunbond non-woven
- Filter layer: Melt-blown polypropylene
- Inner comfort layer: Spunbond non-woven
- Nose wire: Polypropylene-clad adjustable wire
- Attachment: Elastic earloops (A mixture of nylon and polyurethane)
The mask is white, flat-fold style, supplied non-sterile, and packaged in standard pouches.
AI/ML Overview
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