Features & Benefits

  • Maximum ASTM level 3 barrier protection for use in surgical settings.
  • Engineered with proprietary, high-efficiency filter media to improve airborne particulate capture and lower resistance to breathing.
  • Mask filter media captures a minimum of 98% of particles 0.3 microns and larger.
  • Unique, low-profile and contoured design is optimized to accommodate eyewear with exhaled air directed away from the nose to reduce fogging.
  • Maximum comfort for long-term wear environments:
    • Comfortflex™ earloops
    • Adjustable nosepiece
    • Soft inner fabric
    • Lightweight construction
  • Ergonomic design fits most face sizes.

Approvals & Standards

LVL 3_v1
  • ASTM F2100-19 Level 3 Barrier Protection
  • Satisfies FDA Emergency Use Authorization for Use by Healthcare Professionals.

Construction

Color: White
Ear Loops: Nylon/Polyurethane
Nose Clip: Plastic-Coated Steel
Filtering Layer: Polypropylene
Outer Shell Layer: Polyester
Support Layer: Polypropylene
Inner Cover Layer: Polyester
Approximate Weight of Product: 3.5 grams
Country of Origin: USA

Hypoallergenic and not made with natural rubber latex.

Packaging:

CI95™ Face Mask

Part Number: CI95-2020
Unit: 2 Face Masks per Pack
Inner Box: 10 Packs per Inner Box
Outer Carton: 12 Inner Boxes per Carton
240 Masks Total

Test Results

ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks

Property Standard/Test Method Result
Particle Filtration Efficiency ASTM F2299 >98%
Bacterial Filtration Efficiency ASTM F2101 >98%
Pressure Drop EN14683 <5 mm H2O/cm2
Resistance to Blood Penetration @160mm Hg ASTM F1862 No Penetration
Flammability 16 CFR 1610 Class 1, Did Not Ignite

Particulate and Bacterial Efficiency data meet the classification system for mask standard ASTM F2100-19. These test results are provided for comparing performance of face masks under similar laboratory conditions and do not reflect expected levels of filtration efficiency in actual use conditions.

Warnings:

  • This mask is not guaranteed to protect against the risk of contracting disease or infection and is not intended for use in clinical settings where the risk of infection through inhalation exposure is high.
  • Wearer must read fitting instructions and use limitations before use.
  • Maximum performance requires that the face mask be properly fitted to insure a proper seal around the user’s face.
  • For consumer use only. Not for occupational use.
  • Disposable, one time use only.
  • Not NIOSH certified. The product has not been FDA cleared or approved.
  • This product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices, including alternative products used as medical devices, during the COVID-19 outbreak, under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.

Fitting Instructions:

Remove face mask from packaging and hold with ear loops facing outward.

Fully open top and bottom panels, bending nosepiece around thumb at center of nose piece. Ear loops should separate when panels are opened. Make certain bottom panel is unfolded and completely opened.

Place face mask on your face so that the nose piece rests on your nose and the bottom panel is open under chin. Hold the bottom panel securely under your chin. Pull ear loops behind each ear to secure.

Place your fingertips from both hands at the top of the metal nosepiece. Using two hands, mold the nose area to the shape of your nose by pushing inward while moving your fingertips down both sides of the nosepiece. Pinching the nosepiece using one hand may result in improper fit and less effective face mask performance. Use two hands. Adjust the mask placement on the nose and under the chin for a comfortable fit.

Removal Instructions:

Grasp the ear loops behind each ear. Unhook from the ears and pull forward to remove the face mask.

CI95™ Face Mask Information Sheet