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510(k) Data Aggregation
K Number
K220520Device Name
PM Excellence SEQUR 100 Surgical Face Mask
Manufacturer
Date Cleared
2022-12-15
(295 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
PM Excellence LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PM Excellence SEQUR 100 Surgical Face Masks (for single use only) are indicated as protective nose and mouth covering for healthcare workers and patients. These face masks are intended for use in infection control practices as well as any medical or surgical procedure or situations where there is a risk of exposure to microorganism, body fluid, and particulate materials.
Device Description
PM Excellence SEQUR 100 Surgical Face Mask (light blue) for single use only, are pleated 3-ply masks that consist of the following materials: hydrophobic nonwoven PP (polypropylene) spunbond 35 gsm, 17.5cm, light blue (outer layer); nonwoven PP (poly propylene) spunbond 30gsm, 19.5cm, white (inner layer); and nonwoven PP (polypropylene) meltblown 30gsm, 17.5cm, white (middle filter layer). The PM Excellence SEQUR 100 Surgical Face Mask Light Blue also utilizes soft, latex-free elastic earloops and malleable wire nose piece.
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