Makrite 9500-N95

N95 Disposable Respirator

The Makrite 9500-N95 health care respirators are designed to help provide respiratory protection for the wearer against certain airborne particles. They meet CDC guidelines for Mycobacterium tuberculosis exposure control. As disposable particulate respirators, they are intended to reduce wearer exposure to certain airborne particles including those generated by electrocautery, lasersurgery, and other powered medical instruments. As surgical masks, they are designed to be fluid resistant to splash and spatter of blood and other infectious materials.

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Features

  • NIOSH approved N95 rating
  • FDA cleared for use as a surgical mask
  • Fluid Resistance 80 mmHg
  • Flammability Rating Class I
  • Adjustable nose clip
  • Braided and stapled headbands
  • Particulate Respirator and Surgical Mask

Materials

  • The following materials are used in the production
  • Straps Braided Polyisoprene
  • Ultrasonic welding, glue-free and odorless.
  • Nose Clip Aluminium
  • Nose Foam Polyurethane Foam
  • Filter Polypropylene / Polyester
  • Headband design style
  • Shell Polypropylene
  • Coverweb Polypropylene

Use For

  • Intended to be worn by operating room personnel during surgical procedures to help protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
  • Always follow User Instructions and use in manners as indicated

Do Not Use for

  • DO NOT use in industrial settings
  • DO NOT use for gases or vapours (i.e.anesthetic gases such as isoflurane or vapours from sterilants such as glutaraldehyde.)
  • DO NOT use in any manner not indicated in the User Instructions

Approvals and Standards

  • NIOSH/FDA Cleared N95 respirator
  • Meets NIOSH 42 CFR 84 N95 requirements for a minimum
  • 95% filtration efficiency against solid and liquid aerosols that do not contain oil.
  • NIOSH approval number: 84A-5411
  • FDA 510(K): K020474
  • Health Canada Class I medical device
  • Bacterial Filtration Efficiency F2101>99% BFE
  • OSHA Assigned Protection Factor (APF) 10
  • Australia TGA approved

Storage and Transportation

Shelf life of the unopened product is five (5) years from date of manufacture when stored within temperature range of -20°C to +30°C and at less than 80% relative humidity. End of shelf life date is marked on the product packaging. Before initial use, always check that the product is within the stated shelf life. When storing or transporting this product use original packaging provided.

Packaging

20 masks / box; 12boxes / case