Redcliffe Medical Units, Inc. has a enterprise registration with the FDA (30170 60261). No Product Classification, Code QKR (face masks for normal use with out N95 respirator). The masks doesn’t have NIOSH approval and FDA clearance. Mere enterprise registration is not sufficient to authorize industrial transactions exterior this slender scope of every product classification.
NIOSH clearance is a really rigorous and concerned course of. Usually, in spite of everything checks are accomplished (fluid resistance, HEPA filtration effectivity, particular virus/micro organism filtration effectivity, flammability, biocompatability, sturdiness, and many others.), it takes a minimal of 4 months for NIOSH approval to be issued, added of two extra months for FDA clearance.
Additional, UV radiation for masks is a novel, unpracticed thought. Burns can happen inside seconds. FDA clearance for this kind of know-how is purely conjectural.
Soliciting cash by offering untruthful assurances as to sort and diploma of antiviral safety (i.e., N99+ filtration towards Covid-19 or different) or UV disinfection previous to NIOSH approval and FDA clearance, particularly within the context of a nationally-declared well being emergency, is a crime topic to prison and civil liabilities.
FDA APPROVAL CODE SYSTEM
N95/N99 masks are regulated face masks respirators designed to guard towards distinct hazards which have to be clearly laid out in industrial advertisements, and a corresponding NIOSH certification code have to be printed on the masks itself. Unapproved use of those certification marks are prohibited underneath the legislation.
—N95 Licensed Surgical Facepiece Masks – Class II, Code MSH. Are exempt from 510(okay) pre-market notification UNLESS (a) the respirator is meant to stop particular ailments or infections; or (b) the respirator is labeled or in any other case represented as filtering, lowering or killing particular amts of viruses, micro organism, or fungi. Ex. 3M Surgical Masks
—N95 Licensed Facepiece Respirator with Antimicrobial/Antiviral Brokers – Class II, Code OUK. To be used by well being care professionals in surgical settings. Requires 510(okay) pre-market notification. Should match tightly to the face, and is meant to stop particular ailments or infections; or, is labeled or represented as filtering, lowering or killing particular amts of viruses, micro organism, or fungi.
—PAPR – Powered Air Purifying Respirators NIOSH-approved and FDA-cleared. Class II, Code NZJ. Assist scale back [although do not eliminate] the aerosol focus inhaled by the wearer to at the least 1/25th of that within the air. When used correctly, PAPRs present elevated safety and reduce the probability of an infection transmission. Employers will need to have proof offered by the respirator producer that testing of those respirators demonstrates efficiency at a stage of safety of 1,000 to obtain an APF of 1,000. In any other case, their Asserted Safety Issue is 25 APF.
Price $1,400-$1,900 (NIOSH-approved filters: $300 in common). Producer: 3M.
Sars-CoV-2 virus, when airborne, is as small as 0.2microns. Transmission will depend on the extent of virulence within the air. PPEs must be chosen accordingly, particularly in enclosed environments. Ranges of safety towards Covid-19 depend upon environmental circumstances, test-fit to the wearer’s face, and compliance with protocols on correct use, upkeep, and disinfection. No respected medical system firm would make claims of 99.99997% antiviral safety, particularly within the context of Covid-19 –new virus whose properties will not be but totally identified, and topic to genetic modifications.
IMPORTANT NOTICE ABOUT UV TECHNOLOGY
(LED) UV gentle is a novel, unpracticed know-how in facepieces, imposing severe well being dangers relying on the extent of UV gentle publicity–burns can seem inside seconds. July 2020: “Ron Hofmann, president of the Worldwide Ultraviolet Affiliation, and an skilled in UV disinfection on the College of Toronto in Canada, warns towards using UV gentle shut to at least one’s pores and skin. UVC, does have a useful function to play throughout the present pandemic: as a disinfectant device. That is as a result of UVC radiation doesn’t simply harm human DNA; it additionally harms genetic materials in all different dwelling issues on Earth. This consists of viruses, micro organism and fungi.”
“UV robots are essentially the most prevalent units within the UK, plenty of hospitals now have them,’ explains Cath Noakes, an skilled in using UV disinfection in buildings on the College of Leeds. These robots, or trolleys, are wheeled into just lately vacated remedy rooms. For security causes, rooms have to be empty throughout scanning.”
“A lot work stays to be completed to have the ability to safely and confidently transfer this know-how out of the lab and into precise observe’. Guidelines on acceptable quantities of UV publicity would additionally need to be tweaked earlier than the thought might be carried out. ‘Present EU publicity limits could be exceeded fairly shortly,’ says Dan Arnold, gross sales and advertising supervisor at UV Gentle Know-how.”
Comparable Merchandise and Moral Disclaimers
ActiveArmor Clear Facemasks: https://activarmor.com/2020/05/02/how-activarmor-facemasks-compare-to-n95-masks/