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510(k) Data Aggregation
K Number
K211066Device Name
Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3
Manufacturer
Date Cleared
2021-08-19
(129 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
Homtex, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Sovereign America Surgical Mask is intended for use by adult patients and healthcare personnel to protect against the transfer of microorganisms, bodily 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, provided non-sterile.
Device Description
The Sovereign America Surgical Mask, Models 2000SM2 and 2000SM3, is a single use, three-layer, flat-pleated surgical mask with ear loops and a nose piece. Each device is composed of three layers of nonwoven polypropylene, with the outer layer (Layer 1) and inner layer (Layer 3) being spun-bond nonwoven polypropylene, and the middle layer (Layer 2) being melt-blown nonwoven polypropylene. Layer 1 contains a blue pigment. Each device utilizes two elastic ear loops, ultrasonically welded to the mask, to hold the device in place over the users' mouth and nose. The ear loops are polyester spandex elastic, and not made with natural rubber latex. Each device also utilizes a malleable nose piece, made of polypropylene coated aluminum wire, to allow the user to fit the device around the bridge of the nose. Each is provided non-sterile and intended to be a single use, disposable device.
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K Number
K201095Device Name
Sovereign America Surgical Face Mask
Manufacturer
Date Cleared
2021-03-19
(329 days)
Product Code
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
HomTex, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Sovereign America Surgical Mask is intended for use by healthcare personnel to protect both patients and healthcare personnel against the transfer of microorganisms, bodily fluids and particulate material. This is a single use, disposable device, provided non-sterile.
Device Description
The Sovereign America Surgical Mask is a single use, three-layer, flatpleated surgical mask with ear loops and a nose piece. The device is composed of three layers of nonwoven polypropylene, with the outer layer (Layer 1) and inner layer (Layer 3) being spun-bond nonwoven polypropylene, and the middle layer (Layer 2) being melt-blown nonwoven polypropylene. Layer 1 contains a blue pigment. The device utilizes two elastic ear loops, ultrasonically welded to the mask, to hold the device in place over the users' mouth and nose. The ear loops are polyester spandex elastic, and not made with natural rubber latex. The device also utilizes a malleable nose piece, made of polypropylene coated aluminum wire, to allow the user to fit the device around the bridge of the nose. The mask is provided non-sterile and intended to be a single use, disposable device.
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