MEET STANDARD :
. ASTM F2100-19 LEVEL 2
. TYPE II EN14683:2019
Date of Manufacture:
1) Wash your hands before wearing a mask.
2) Make sure that the light-color side of the mask is facing inwards,and the metal strip end is facing up,and hang the rope at both ends on the ears.
3) Fasten the metal strips on both sides of nose bridge with both hands so that the upper end of the mask is close to nose bridge.
4) Stretch the mask down to the lower jaw so that the mask does not crease.
This product is disposable and cannot be re-used after cleaning.
It is not recommended to wear the mask in the below condition: bad air flow,no smooth breathing and during sleeping.
FREQUENTLY ASKED QUESTIONS:
Do you have questions about PHARMOZY™ Medical Face Masks and ASTM mask protection standards？
Below you will find the answers you need to the frequently asked questions we receive about medical face masks and ASTM standards.
What is ASTM?
ASTM refers to the American Society of Testing and Materials (ASTM). ASTM is an international standards organization that develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services—including those in healthcare.
How long is my medical face mask effective?
The filtration efficiency and protective ability of a medical face mask is compromised when the mask becomes wet, torn or dislodged. Generally speaking, the higher protection value of a mask the longer it will maintain filtration; however, there is no set rule for how long a mask should be worn as it depends on humidity levels, respiration rate, nasal discharge, talking, etc. A medical face mask should be worn for only one patient procedure or visit. If a mask gets wet or soiled it should be replaced.
What are ASTM standards for medical face masks?
ASTM standards are referenced by the Food and Drug Administration (FDA), as the endorsed standard in the United States. The current standard ASTM F2100-11 (2011) specifies the performance requirements for Medical Face Masks with five basic criteria:
When comparing test results it is important to note the size of the test particles used, as use of a larger particle size will produce a misleading PFE rating.
5.5 In addition to the above tests, all medical face masks must be tested to an international standard (ISO 10993-5, 10) for skin sensitivity and cytotoxic tests to ensure that no materials are harmful to the wearer. Tests are conducted on materials used in construction of the mask which come in contact with the user's skin.
Are there different levels of protection with ASTM-rated medical masks?
Yes there are three unique levels of protection with ASTM-rated medical masks. Level 1 masks have the lowest barrier of protection, while Level 3 masks have the highest barrier of protection. For greater clarity on the differences, refer to the information in the charts below:
What is the purpose of a medical Surgical face mask?
In the Operating Room (OR), surgical masks protect the sterile field from possible contamination, primarily as a result of coughing, sneezing or talking. A mask may also protect clinicians from the byproducts of surgical procedures such as bone chips, splashes of body fluids, and smoke plume resulting from laser or electrosurgical techniques.
Outside of the OR masks are used for standard precautions to protect clinicians and patients from pathogens that may spread by blood or other body fluids, secretions or excretions. Surgical and procedure masks are effective against droplet transmission.
What is the difference between a surgical mask and a 3PLY Medical procedure mask?
A surgical mask is used inside the operating room or within other sterile procedure areas to protect the patient environment from contamination. It also protects the clinician from contaminated fluid or debris generated during the procedure. Surgical masks have ties so that they can be adjusted for fit, and are tied over top of a surgical cap or a bouffant cap.
A 3PLY Medical Procedure Mask is used for performing patient procedures, or when patients are in isolation to protect them from potential contaminants. Medical Procedure masks are used to protect both patients and staff from the transfer of respiratory secretions, fluids or other debris. Procedure masks are used for generally "respiratory etiquette" to prevent clinicians, patients and visitors from spreading germs by talking, coughing, or sneezing. Procedure masks have ear loops for quick donning, and since they do not slide on the hair, they can be worn without a surgical cap.
Why is the fit of a medical face mask important?
A medical face mask is only as effective as its fit. There should be no gaps along the side, around the nose or under the chin that would allow air and droplets to bypass the filter medium. The mask should always be properly adjusted to fully cover both the mouth and nose. A well-fitting mask stays in place over the nose and cheeks and even a regular mask will prevent fogging of eyeglasses if it fits properly. Masks should not be worn underneath the nose or dangling around the neck – they should either be fully on, or disposed of.
How do I ensure a good fit?
There are several things that contribute to a good fit. The most important consideration is the nose piece. It should mold over the nose and cheeks and maintain its shape over time. It should not kink or break when adjusted. Individuals with wider faces should select a mask that ensures full coverage over the face and under the chin. The upper tie should sit at the crown of the head, and the lower tie should be tied behind the neck to hold the sides of the mask against the face to prevent any gaping.
How do I know if the medical face mask is on correctly?
Generally, there are three things you should look for to ensure your mask fits correctly:
What tests or ratings should I rely on to ensure my mask is safe?
Specifications developed by the American Society of Testing and Materials (ASTM) are generally accepted as the industry standard. Beware of mask ratings that do not follow ASTM guidelines. Some manufacturers may refer to “filtration rates” or the “number of layers” as an indication of effectiveness. These vendors may not be adhering to the ASTM standards and should be questioned for specific test data.
What else should I know about medical face masks?
All individuals using medical face masks must be aware of the protective capabilities of the mask being worn. Healthcare workers should assess their risk of exposure to blood, body fluids, excretions and other potential hazards—and choose their mask accordingly.
A medical face mask is considered to be contaminated once it has been used, and should be discarded immediately. A mask should be removed by the edges or the ties rather than the front panel.
As part of Personal Protective Equipment (PPE), medical face masks with integrated visors are recommended to ensure compliance with eye protection. PPE includes all equipment and apparel that prevents potentially infectious material from contaminating clothing, skin, eyes, mouth, nose, or other mucous membranes.