TECHNICAL
...
IMPORTANT NOTE: OxiClear Face Mask are designed as filtering face mask for particles and is marketed for general use without fit testing on each mask wearer. OxiClear Face Mask Technical File includes Fit Testing on human test subjects to confirm filtering efficiency across a series of motions in independent fit testing lab. The filtering efficiency of a mask depends on a good seal around the nose and mouth. NIOSH certifies respirators for occupational safety when administered through OSHA Compliant Respirator Safety Program to include Fit Testing on each worker. OxiClear Face Mask is marketed directly to the public for general use. For this reason, NIOSH does not certify OxiClear Face Mask for medical or workplace. OxiClear Face Mask shows conformance to US standards in testing. The technical below provides conformance testing and international certificates to support OxiClear Face Mask product safety and efficiency.
RESPIRATORY MASKS CONFORMANCE TESTING
Defence Research and Development Organisation - (DRDO) Ministry of Defence of the Government of India Filtering efficiency meets requirements and achived 99.46% filtering of particles over .3 microns.
99.46% Particle Penetration Filtering Efficiency, Filter class provides >99.9% Viral and Bacterial Filtering Efficiency, Safe and Comfortable Breathing Resistance, Valves Tested for inward valve leakage. OXICLEAR CONFORMS TO THESE STANDARDS IN TESTING:
The filter efficiency as stated in 42 CFR Part 84.181 is a minimum efficiency for each filter of ≥ 95% ( ≤ 1% penetration) . The test articles submitted by the sponsor conform to the criteria for filter efficiency. NOTE: OxiClear face mask is marketed for general use directly to consumers and is NOT CERTIFIED by NIOSH/CDC/NPPTL for workplace where an OSHA Compliant respiratory protection program to include Fit Testing on each individual is required.
OxiClear state of the art activated carbon filters, are also infused with other compounds like magnesium dioxide and copper oxide to remove even more hazardous pollutants from the air, such as carbon monoxide, ethylene oxide, and ozone. OxiClear filters are also more adept at preventing a build-up of bacteria that can occur naturally over time.
MANUFACTURING SPECIFICATIONS
OxiClear Face Mask are manufactured under Quality Plan at our ISO Certified plant in Machhiwara Punjab India. Summary of testing and Certifications: Important Note: OxiClear Face Mask is designed as filtering face mask for helping to protect from particles. NIOSH does not certify respirators that are marketed directly to the general public, without OSHA Compliant respiratory protection program to include Fit Testing on each individual. OxiClear face mask is NOT a NIOSH Certified mask for medical or workplace. Our filtering masks are designed to present to the public an important and efficient tool for protecting health. OxiClear CONFORMS in testing to standards established for workplace masks. FIT: The filtering efficiency of a mask depends on a proper fit. This is why we offer OxiClear Face Mask in adjustable size. Also OxiClear face mask is Quantitatively Fit Tested on human subjects to make sure the filtering efficiency is retained over a series of motions like walking, head movements, bending over, talking, etc. PRODUCT CONFORMS to standards in testing at independent testing labs.
99.46% Particle Penetration Filtering Efficiency The inhalation resistance criteria as stated in 42 CFR Part 84.180 is an initial inhalation not exceeding 35 mm water column height pressure. The test articles submitted by the sponsor conform to this criterion for airflow resistance. The exhalation resistance criteria as stated in 42 CFR Part 84.180 is an initial exhalation not exceeding 25 mm water column height pressure. The test articles submitted by the sponsor conform to this NIOSH criterion for airflow resistance. Determination of Valve Leakage
According to 42 CFR Part 84.182 the leakage between the valve and valve seat shall not exceed 30 mL/min. The test articles submitted by the sponsor conform to the criteria for exhalation valve leakage. Viral Filtration Efficiency
>99.9% There were no detected plaques on any of the Andersen sampler plates for this test article. Bacterial Filtering Efficiency
>99.9% There were no detected colonies on any of the Andersen sampler plates for this test article.
OXICLEAR BRAND GUIDELINES: TESTING, TECHNICAL, CERTIFICATIONS
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.