The ASTM standard requires that masks have a Delta P of less than 5.0, as a higher value would be considered too “hot” for general medical or surgical use. Masks with a Delta P of less than 4.0 are considered acceptable, while masks with a Delta P less than 2.0 would be considered “cool”.
ASTM specifies testing with a droplet size of 3.0 microns containing Staph. Aureus (average size 0.6-0.8 microns). In order to be called a medical/surgical mask, a minimum 95% filtration rate is required. Moderate and high protection masks must have bacterial filtration rates greater than 98%.
The quality of masks should be rigorously checked to prevent defective products from making it to the market, including checking for flaws such as embedded hair or stains, measuring the width of the mask, checking for the presence of straps, and determining that the straps are correctly attached to the mask.
① Visually inspect the appearance of the mask sheet should be neat and intact, with no stains or damage on the surface.
② The nose bridge is centered in the center of the mask to check whether the material of the nose bridge meets the requirements of the order. The nose bridge is divided into: double wire/single wire/plastic strip
③ The spot welding position is located at the four corners of the mask face cloth.
④ Inspection standard of adult mask size: length 17.5CM, width 9.5CM, and the unfolded size is not less than 16.5CM. Children's mask size inspection standard: length 14.5CM, width 9.5CM, unfolded size not less than 15.5CM.
⑤ The inspection standard of the bridge of the nose: no less than 11cm for adults; no less than 8cm for children.
⑥ Earhook inspection standard: the length range is between 15.5~16CM; The pulling force of the earhook with a spring dynamometer should not be less than 10N.
⑦ Inspection standard for mask weight: cut and stretch both sides of the mask, take an original piece with a film beater, and put the face cloth. The filter paper and bottom are placed on an electronic balance and weighed. The weight data obtained must meet the requirements of the order.
⑧ The size and printing of the certificate, middle box and outer box must be checked and verified in accordance with the contract electronic draft
Founded in 2006, Wellmien has grown to a company specializing in disposable medical supplies and Personal Protection Equipment (PPE), integrating with design, manufacture and sales capacity. Our sales headquarter is in Suzhou, Jiangsu and manufacturing plants cover a total area of 8,000m2 including 1,500m2 of clean room.
Wellmien provides globally medical care and food processing facilities with products including face masks, gowns, coveralls, aprons, bouffant caps, shoe covers, sleeve covers, under pads, disposable gloves, wound-care products, isolation gowns, first-aid products and surgical packs etc. Our products are best sold to worldwide markets and widely applied to different settings such as hospitals, care centers, wholesalers, government agencies or institutes, food industries and households, etc. With excellent OEM services, our annual sales exceed 20 million USD.
Wellmien is ISO13485 certified and implements a strict Quality Management System (QMS). Our main products are approved by US FDA and EU CE certified. With superior products and services, our company has won the trust and support from new and old customers all over the world. If you have any inquiry, please do not hesitate to contact us!