Adult use only. This product may be used to cover an adult user’s nose and mouth to provide a physical barrier to airborne particulate matter. No uses or suitability for particular purposes are implied or suggested.
This mask is NOT intended or approved for use:
- In settings where significant exposure to liquid, bodily, or other hazardous fluids, may be expected.
- In a clinical setting where the infection risk level through inhalation exposure is high.
- In the presence of a high intensity heat source or a flammable gas.
Filter media Materials used in this mask are in compliance with general FDA requirements and 21 CFR 177.1520 for Olefin polymers.**
Filter media layer used in this mask were tested by the media manufacturer to include 85.0 Lpm flow rate or greater, with resistance of 7.4 mm/H2O, 30.0% penetration.# Resistance and penetration results were measured using the TSI-8130A automated filter test unit.# The challenge aerosol is a NaCl with a mean particle size of 0.3 micron.#
# This is a restatement of manufacturer testing of filter layer materials, and does not imply or claim particulate filtration ability of this product.
**As reported in filter media manufacturer’s documentation. This statement has not been independently verified by a third party or the fda. This product is not intended or approved for antimicrobial or antiviral protection or related uses.
Statement Pursuant To Sec. 564 of the Federal, Food, Drug, And Cosmetic Act 21 U.S.C. 360bbb-3
This product has been authorized by The FDA under an EUA for use by health care providers as personal protective equipment to help prevent the spread of infection or illness in healthcare settings and by the general public to help slow the spread of the virus during the COVID19 pandemic. 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.
Prior to use of this product: Health care providers should obtain current status of The ACT, including revocation and termination information. Please refer to www.Fda.gov.
Directions For Use
1. WASH THOROUGHLY
WASH HANDS FOR AT LEAST 20 SECONDS USING SOAP AND WATER.
DRY HANDS USING A CLEAN PAPER TOWEL PRIOR TO PUTTING ON A FACE MASK.
2. ORIENT MASK
3. ADJUST AND SEAL
PULL THE BOTTOM OF THE MASK OVER YOUR MOUTH AND CHIN.
MOLD THE BENDABLE NOSE PIECE TO THE SHAPE OF YOUR NOSE BY PINCHING AND PRESSING DOWN ON IT WITH YOUR FINGERS.
4. POSITION MASK
HOLD THE MASK BY BOTH EAR LOOPS AND PLACE ONE LOOP OVER EACH EAR.
POSITION THE BENDABLE NOSE PIECE AGAINST THE BRIDGE OF YOUR NOSE.
5. DISCARD MASK AFTER A SINGLE USE
REMOVE THE FACE MASK AFTER A SINGLE USE WITHOUT TOUCHING THE FRONT OF THE MASK. DISCARD THE USED FACE MASK IN A CLOSED BIN.
FACE MASKS ARE NOT REUSABLE. DO NOT ATTEMPT TO WASH OR REUSE A MASK. DO NOT USE A SOILED, TORN, DAMAGED, OR DAMP MASK.