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510(k) Data Aggregation
K Number
K202903Device Name
Surgical Face Mask
Manufacturer
Date Cleared
2022-03-24
(541 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
**Rizhao Sanqi Medical **& Health Articles Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. When worn properly, 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 Face Masks are 3-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (Spandex) or ties (polypropylene). A malleable nose clip is placed in the layers of facemask for comfort and individualized fit. The surgical face mask will be provided in blue, white, pink, green, vellow and with the option for a visor. The surgical face masks are single-use, disposable devices, provided non-sterile.
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