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510(k) Data Aggregation
K Number
K203776Device Name
Surgical Masks, Model SNN200640 & MN112
Manufacturer
Date Cleared
2021-03-25
(87 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
SQ Medical Supplies Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Surgical Masks are 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(s), provided non-sterile.
Device Description
The Surgical Masks are Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose. The Surgical Masks are manufactured with three/four layers. The surgical mask has two models which are SNN200640 and MN12. They are basically the same, the only difference is the SNN200640 has the three layers and MN112 has the fours layers. The Surgical Masks are single use, disposable device, provided non-sterile.
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