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510(k) Data Aggregation
K Number
K190308Device Name
Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)
Manufacturer
AMD Medicom, Inc.
Date Cleared
2019-09-17
(217 days)
Product Code
OXZ
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
AMD Medicom, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Mask (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Mask, Medicom SafeMask Premier Procedure Earloop Face Mask (ASTM Level 1) and Medicom SafeMask Premier Pediatic Procedure Earloop Face Mask are intended to be worn by the patient/ child (recommended 4-12 years of age). The face mask is to be placed on nose and mouth as a protective barrier to provide respiratory protection in procedures or situations where there is a risk of microorganism, body fluid and particulate aerosol transfer. It is a single use, non-sterile disposable device that is recommended for use in healthcare settings with appropriate adult supervision.
Device Description
Medicom Pediatric/Child's Face Mask is a manufactured pleated three-layer mask construction utilizing ultrasonic bonding. The patterned (ink printed) outer layer is composed of spunbound polypropylene (SBPP) material. The filter media is composed of meltblown polypropylene (MBPP). The inner is either tissue/ cellulose or a spunbound polypropylene (SBPP) layer. Bindings are composed of nonwoven polyester and earloops are made of flat elastic knitted polyester band. A malleable polypropylene nosepiece (made of plastic covered iron wire or 100% aluminum piece) is placed within the bindings for comfort and individualized fit around the wearer's nose. Medicom Pediatric/Child's Face Mask is a non-sterile single use disposable device. The device safety of effectiveness is not affected by storage conditions with no shelf life.
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