TECNOL Medical respirator now registered as a medical device

TECNOL Medical respirator now registered as a medical device

Fort Worth, TX

TECNOL Medical Products, Inc. has received permission from the FDA to market its PFR95 Particulate Filter Respirator and Surgical Mask with FluidShield Protection as a medical device. The clearance means that the PFR95 meets the Center for Disease Control guidelines for tuberculosis exposure control. Previously marketed as an N95 respirator approved by NIOSH, the FDA clearance expands the range of health care applications for which the PFR95 is appropriate and its total available market, says a company spokesperson. TECNOL is a provider of disposable face masks and patient care products to the U.S. hospital market, as well as to the alternate health care, dental, industrial and consumer markets worldwide. — SES

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