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FDA has granted 510(k) clearance to Teleflex's ISO-Gard Mask with ClearAir technology

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Teleflex's ISO-Gard Mask with ClearAir technology.

The ISO-Gard Mask is designed to reduce waste anesthetic gas (WAG), exhaled by the patients who are recovering in the Post Anesthesia Care Unit (PACU), within a nurse's breathing zone.

The multi-purpose mask reduces WAG while delivering oxygen to the patient through the patent-pending ClearAir technology that provides unidirectional flow of oxygen through the mask to assure maximum FiO2.

Teleflex anesthesia and respiratory division president Cary Vance said with the provision for reducing the amount of WAG within the breathing zone, hospitals can better comply with Occupational Safety and Health Administration (OSHA) and NIOSH recommendations for workplace safety.

"This unique device exemplifies Teleflex's commitment to provide solutions that enhance provider safety," Vance added.

Source: http://anesthesiarespiratorydevices.medicaldevices-business-review.com/news/fda-clears-teleflex-waste-anesthetic-gas-reducing-technology-120413
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FDA Clears Teleflex Waste Anesthetic Gas Reducing Technology