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510(k) Data Aggregation
K Number
K232968Device Name
Grande Medical Masks, Model SF-600
Manufacturer
Date Cleared
2024-06-06
(259 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Golden Grande Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Grande Medical Masks is intended to be worn to protect both the patient and healthcare personnel from the 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. The Grande Medical Masks are single use, disposable device, provided non-sterile.
Device Description
Grande Medical Masks are 4-layer surgical masks that covers the user's nose and mouth and provides a physical barrier to fluids and particulate materials. This device is non-sterile and for single use only. The mask is constructed of nonwoven fabric, including the bottom layer, surface layer 1, surface layer 2 and middle layer, and is provided with ear loops and nose clip.
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