Product Description: Medical Protective Mask Model: Folding Mask with Ear Loop / 15.5cmx10cm Color: White FDA FEI #: 3016711197 FDA Product Listing under EUA: MSH Test Standard: GB 19083-2010 Report No.: 200069595 NMPA Registration Certificate #: ShanXieZhuZhun 2020140026 Intended Use:This protective mask is intended to help reduce the wearer’s exposure to certain airborne particles present in a medical working environment. It is fluid resistant to blood splatter and other biological fluids.
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BEWARE OF COUTERFEIT!
Open the mask flat, with the nose clip facing away from your face and located at the top of the mask
Holding one of the ear bands in each hand, place the mask against your chin
Pull each ear band behind your ear and adjust the ear band until it feels comfortable
Using both hands, place your fingers in the middle of the metal nose clip and press inward towards your face while moving your fingertips along the nose clip outward towards the sides until the clip is fully pressed and molded into the shape of the bridge of your nose. Warning: Using only one hand to mold the nose clip may affect the fit and tightness of the mask.
Before entering the work area, check the mask for tightness and any leaks around the face. Place both hands completely over the mask and exhale. If air leaks around the nose, remold the nose clip as outline in step 4. If air leaks around the edges, adjust the position of the ear bands and reposition the mask snuggly on your face.
Precautions and Contraindications
1. WARNING: Respiratory protective equipment does not eliminate the risk of contracting any disease or infection. Incorrect use may result in sickness or death. For proper use, see mask usage instruction
2. This respirator is not intended for use with beards, other facial hair or any condition that would prevent a good seal between the face and the outside edge of the respirator.
3. This respirator does not protect against harmful gases and vapors and is not suitable for anoxic (oxygen deficient)environments, underwater operations or use as fire respiratory protective equipment.
4. This respirator is not intended for industrial use and is not designed to be used by children.
5. Mask may be used until damaged, dirty (contaminated with blood or fluids) or breathing resistance becomes high.
6. This product is disposable and must be discarded after every use
7. After the product is used, it shall be handled according to the requirements of the hospital and the environmental protection department.
8. This product has been sterilized with ethylene oxide. Before use, please check whether the packaging is in good condition and confirm the external packaging for production date and use within the sterilization period.
Description This protective face mask has been designed to provide respiratory protection to the user in a medical environment. It has a filter efficiency level of at least 95% against particulate aerosols free of oil. It is resistant to fluids and should only be worn one time. This single size mask will fit a wide range of face sizes.
Product Composition This product consists of 4 layers: outside layer is non-woven fabric, middle filter layer is a blown fabric, second middle layer is hot air cotton and inside layer is non-woven fabric
Storage and Shelf Life: Keep in a cool, dry, well ventilated area in the original packaging. Store in an environment with relative humidity <80% and between -4°F (-20°C) and 104°F (40°C). Store away from direct sunlight, extreme heat, corrosive gases, damaging chemicals, dust and contaminated areas. When stored properly, sterilization period is 2 years. Check expiration date on individual package.
Please refer to the instructions before using.
Dr. Astro Inc. Made in China
Company and Product Authentication
Report No. 200069595
This product is manufactured to the National Standard of the People’s Republic of China GB 19083-2010: “Technical Requirements for Protective Face Masks for Medical Use”. This Standard specifies the technical requirements, test methods, markings and instructions for use, packaging, transportation and storage for protective face mask for medical use. This Standard is applicable to non-powered air-purifying medical protective face mask – used in medical service environments to filter particulate matters in air and to separate spray, blood, body fluid, secretion etc.
The mask was tested to have Filtration Efficiency of >99% by the independent test laboratory, GTTC Group, a Provincial-level government official Test Lab accredited by CNAS, IDFB, and AWI (woolmark). http://www.gttc.net.cn/