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Surgical masks are considered medical devices class 2. The FDA has drafted standards to which manufacturers have to comply in order to receive a licence to sell the products on the market. The same standards apply to surgical masks, procedures, isolation, dental interventions and laser treatments. Fabric Face Mask (Reusable Mask) Anti-Bacterial - UltifreshDue to the global shortage of surgical mask, we have R&D and is the first in Singapore to produce reusable mask with BFE99% (Bacterial Filtration Efficiency).We added Adjustable Ear Loops to ensure our mask fits all face sizes. Face Mask and ISO13485 - ISO Consultant Gabriel For example:When a mask manufacturer passed an ISO13485 certification audit by UK accredited certification body (such as SGS, BV, Lloyds, BSI ..) covering operation and management of a company. The mask manufacturer received a UK Accredited ISO13485 certificate. The ISO13485 certificate states that the operation and management of masks manufacturers meet ISO13485 requirements.
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