IMPORTANT NOTE: OxiClear masks are filtering face masks for particles, marketed for general use without fit testing on each individual wearer. The OxiClear technical file includes quantitative fit testing on human subjects at an independent laboratory, confirming that filtration performance holds across a series of motions. The filtering efficiency of any mask depends on a good seal around the nose and mouth.
NIOSH certifies respirators for occupational use administered through an OSHA-compliant respiratory protection programme that includes fit testing on each worker. OxiClear masks are marketed directly to the public for general use, so they are not NIOSH-certified for medical or workplace settings. What we publish instead is the testing itself: the sections below set out each result, what it measures, and where it comes from.
Defence Research and Development Organisation (DRDO), Ministry of Defence, Government of India. An OxiClear mask sample tested at a DRDO laboratory recorded up to 99.46% particle filtration efficiency for particles larger than 0.3 microns under the stated test conditions. The full report is linked at the end of this page.
Independent laboratory testing of the submitted OxiClear test articles recorded 99.46% particle filtration efficiency, viral and bacterial filtration efficiency above 99.9%, breathing resistance well within comfortable limits, and exhalation-valve leakage within the tested criteria.
REFERENCE STANDARD: The filter-efficiency criterion in 42 CFR Part 84.181 is a minimum efficiency of 95% for each filter (at most 1% penetration). The submitted test articles met the filter-efficiency criteria in testing.
NOTE: OxiClear masks are marketed for general use directly to consumers and are not certified by NIOSH/CDC/NPPTL for workplaces where an OSHA-compliant respiratory protection programme with individual fit testing is required.
Every OxiClear filter combines particulate filtration layers with an activated carbon layer. Activated carbon is used in air filtration for its extremely high adsorptive surface area; in the OxiClear filter system it supports the particulate layers, which do the primary work of capturing fine airborne particles. Filters are replaceable and are not washable. Replace the filter every 21 days or 100 hours of use, whichever comes first.
OxiClear masks are manufactured under a documented quality plan at our own facility in Machhiwara, Punjab, India. OxiClear Private Limited holds a Form MD-42 registration certificate issued by the State Licensing Authority, Punjab, to sell, stock, exhibit, offer for sale or distribute medical devices.
SUMMARY OF TESTING AND DOCUMENTATION
Important Note: OxiClear masks are general-use filtering face masks for particles. NIOSH does not certify respirators marketed directly to the general public outside an OSHA-compliant respiratory protection programme with individual fit testing, so OxiClear masks are not NIOSH-certified for medical or workplace use.
Where a recognised workplace-mask standard defines a test method, OxiClear test articles have been evaluated against it. The results are listed below.
FIT: Filtration only counts if the mask seals, which is why fit is engineered, not assumed: an adjustable nose clip, side cords and a detachable headband shape the mask to the wearer. OxiClear masks are quantitatively fit tested on human subjects to confirm that filtering efficiency holds through walking, head movement, bending and talking.
BREATHING RESISTANCE: In testing, OxiClear masks measured in the lowest third of the reference range for breathing resistance, which is why they stay comfortable through long wear.
QUALITY MANAGEMENT SYSTEM: OxiClear has established and maintains a Quality Management System (QMS), which includes a Quality Manual and detailed standard operating procedures. OxiClear operates under the QMS to ensure its business processes are focused on consistently meeting customer requirements and enhancing customer satisfaction of the OxiClear brand. OxiClear strives to maintain a high level of product quality and, through its manufacturing facilities, seeks to continuously improve its products.
PARTICLE FILTRATION: Up to 99.46% particle filtration efficiency for particles larger than 0.3 microns under test conditions, recorded on an OxiClear mask sample tested at a DRDO laboratory.
AIRFLOW RESISTANCE (42 CFR Part 84.180)
The inhalation-resistance criterion in 42 CFR Part 84.180 is an initial inhalation resistance not exceeding 35 mm water column. The exhalation-resistance criterion is an initial exhalation resistance not exceeding 25 mm water column. The submitted OxiClear test articles met both criteria.
VALVE LEAKAGE (42 CFR Part 84.182)
The criterion allows leakage between the valve and valve seat of no more than 30 mL/min. The submitted OxiClear test articles met the exhalation-valve leakage criterion.
VIRAL FILTRATION EFFICIENCY
Above 99.9% for the submitted test article: no plaques were detected on any of the Andersen sampler plates in testing.
BACTERIAL FILTRATION EFFICIENCY
Above 99.9% for the submitted test article: no colonies were detected on any of the Andersen sampler plates in testing.
