![]() Wearers should be fit-tested before wearing a N95 respirator. ![]() They should be disposed of once used in accordance with the healthcare facility’s policy.ģ. Procedure, surgical tie and even surgical N95 respirators are disposable medical products and are intended for single use only which is clearly reflected on the product labeling. The combination of materials are designed to protect the wearer and the patient from the transfer of microorganisms, splashes of blood, or other droplets of potentially infectious bodily fluids. Surgical tie and procedure masks, along with surgical N95 respirators meant for use in medical settings are made primarily with non-woven fabrics, along with a filter material called meltblown. Medical masks are intended for single use. These are made and certified in China and are not approved by NIOSH.Ģ. While not all N95s are the same, they must filter at least 95% of very small particles, including bacteria and viruses from the air, breathed through the mask. Per the CDC, surgical N95s should be reserved for use by healthcare personnel. A surgical N95, also referred to as a medical respirator, provides protection from both airborne and fluid hazards (e.g., splashes, sprays). Not all N95 respirators are approved as surgical face masks. Surgical N95 respirators have been approved by NIOSH and have been authorized for use by the FDA. A mask that has an ASTM level 1 protection should not be used in areas where there is moderate to high risk of fluid exposure. Depending on the test results, a mask may be rated ASTM level 1, 2 or 3 with the highest performance rated level 3. To carry an ASTM rating, the FDA requires that the mask be tested for bacterial filtration, differential pressure (breathability), particulate filtration, fluid resistance and resistance to flame spread. These standards serve as a baseline to help ensure safety and quality. ASTM International develops and publishes voluntary consensus standards for a wide variety of products and services. There are industry-specific standards that measure mask performance that also impacts where the mask should be used in the healthcare setting. NIOSH-approved N95 respirators have over the head elastic bands, or head straps, to hold the respirator firmly in place and create a seal, creating their high level of protection. Procedure masks are affixed with stretch loops behind the ears, while surgical tie masks, which are intended for use in the operating room, have two sets of ties for a more secure fit to the face. Visually, the easiest way to tell masks apart is by the attachment that fixes it to the face. Masks that are authorized by the FDA are referred to as medical face masks. Generally speaking, face masks fall into three key sub-groups: procedure masks, surgical tie masks, and N95 respirators. There are different types of medical face masks. Technical Product Information – IFU’s, Delarations of Conformityġ. ![]() Surgical Drapes, Packs & Equipment Covers.
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