Instructions

Sovereign America
Surgical Mask
Model: 2000SM1


This “Instructions for Use” contains information on how to use the Sovereign America Surgical Mask, Model: 2000SM1.


Intended Use of Product:
The Sovereign America Surgical Mask is a non-sterile, nonwoven 100% polypropylene, three-layer, flatpleated, single use, disposable surgical mask. The 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.


Surgical masks are a loose-fitting device worn over the user’s nose and mouth. Surgical masks may be effective in blocking splashes and large particle droplets; however, because of the loose fit between the surface of the surgical mask and the user’s face, leakage can occur around the edge of the mask when
the user inhales. Therefore, a surgical mask may not provide the user with a reliable level of protection from inhaling smaller airborne particles and is not considered respiratory protection. For this reason, surgical masks are not recommended for use in aerosol generating procedures and any clinical
conditions where there is significant risk of infection through inhalation exposure. In such clinical conditions, a filtering facepiece respirator (such as an N95 respirator) with a tight fit is recommended to provide a more reliable level of respiratory protection against pathogenic biological airborne particulates.
It may be worn and safely discarded after single use by a single individual following the instructions provided by your facility’s infection control policies.


Materials:

  • Mask Body Materials: Three-Layers of Non-Woven 100% Polypropylene: Outer Layer of Blue Spunbond, Polypropylene, Middle Layer of White Meltblown Polypropylene, and Inner Layer of White Spunbond Polypropylene
  • Elastic Ear Loops: Polyester Spandex Blend
  • Nose Piece: Polypropylene Coated Aluminum Wire

ASTM F2100 Level 1 Performance Criteria:
ASTM F2100 Level 1
Fluid Resistance (mm Hg): 80
BFE (%) @ 3.0 μm: ≥ 95%
PFE (%) @ 0.1 μm: ≥ 95%
ΔP (mm H2O/cm2) ˂ 5%
Flame Spread: Class 1


Fitting Instructions:
Step 1: Place Ear Loops over ears
Step 2: Adjust nosepiece for comfortable fit
Step 3: Pull pleats down below chin


Removal (Doffing) Instructions:
Step 1: Grasp Ear Loops to remove
Step 2: Remove slowly without touching mask front or face
Step 3: Discard mask

Important Information You Need to Know Before Using the Sovereign America Surgical Face Mask:


This product does not contain components made from natural rubber latex.


Warnings:
1. This is a single use, disposable product. Discard after use.
2. Inspect before use. Do not use if packaging or masks appear opened, defective, altered, damaged, or
broken.
3. Mask should be replaced after short-term use.
4. Do not use if user experiences discomfort or adverse reaction.
5. Do not use if mask becomes contaminated, soiled, or wet.
6. This product should be stored in a dry, well ventilated environment.
7. Do not use this product in a clinical setting where the infection risk level through inhalation exposure is high.
8. Do not use this product for antimicrobial or antiviral protection.
9. Do not use this product for infection prevention or reduction.
10. This product does not provide particulate filtration.
11. Do not use this product in the presence of a high intensity heat source, flammable or corrosive gases.


Manufacturer:
Homtex, Inc.
2125 2nd Ave. SW Cullman, AL 35055
www.homtex.com