Bodygard gowns, Myflon masks and FLX coveralls are supplied in the US by Bodyguard Advanced Materials LLC (also trading as Auris Advanced Materials), 60 SW 13th St, Miami, FL 33130. Quality documents are on our Certificates page.
No. Only the three products in the first answer hold FDA 510(k) clearances. Our FLX coveralls are industrial protective clothing. They are rated to European standards (for example, the FLX 2000 has an EU Declaration of Conformity for Category III, Type 5/6). Our scrub suits, drape packs and OR towels are not covered by any 510(k) clearance.
FLX 500: general-purpose work where you just need to keep clothes clean. FLX 1000: double-layer polypropylene spunbond for light protection against non-toxic liquids and dust. FLX 2000: microporous laminate, Type 5/6, for hazardous dust and limited chemical splash (spray painting, asbestos work, pesticides). FLX 2000 Cool: FLX 2000 with a breathable back panel for warm conditions. FLX 3000: high-visibility yellow coverall with a barrier against many inorganic acids and bases.
These are European protective-clothing types. Type 5 (EN ISO 13982-1) means protection against hazardous dry particles. Type 6 (EN 13034) means limited protection against light sprays and splashes of liquid chemicals. Neither type is for pressurized jets or heavy liquid exposure (Types 3 and 4). The FLX 2000 is certified Category III, Type 5/6. See our Coverall Standards page for all six types.
It is a blue, three-layer, flat-pleated ear-loop mask (175 x 95 mm) that meets ASTM F2100 Level 3. The 510(k) summary lists these results: fluid resistance (ASTM F1862) passed at 160 mmHg; bacterial filtration efficiency (ASTM F2101) and particle filtration efficiency (ASTM F2299) both met the 98% or higher criterion; differential pressure was below 6.0 mm H2O/cm2; flammability was 16 CFR 1610 Class 1. It also passed cytotoxicity, irritation and sensitization testing.
Yes. Both Bodygard SFS gowns (Level 3 and Level 4) are supplied sterile. They are sterilized with ethylene oxide (EO) to a sterility assurance level (SAL) of 10^-6, and they are single-use, disposable devices.
SFS stands for SMS nonwoven / film / SMS nonwoven. A barrier film is laminated between two layers of SMS nonwoven. According to the FDA 510(k) summaries, both the Level 3 and the Level 4 gown are poly-reinforced, weigh 60 g/m2, are made with ultrasonic bonding and come in blue. The Level 4 gown also has knit cuffs and a hook-and-loop closure.
Both levels come from ANSI/AAMI PB70, which rates liquid barrier performance. A Level 3 gown has to pass a water-impact test (AATCC 42, 1.0 g or less) and a hydrostatic pressure test (AATCC 127, 50 cm or more). A Level 4 gown has to pass ASTM F1671, which means no penetration of a virus-sized bacteriophage in simulated blood at 2 psi. Level 3 is meant for moderate-risk situations. Level 4 is for high-risk, long or fluid-intense procedures.
No. A 510(k) is a premarket notification. FDA reviews the data and decides whether the device is "substantially equivalent" to a device already legally on the market. If it is, the device is cleared and may be marketed in the US. "Approval" is a different process (premarket approval, PMA) that surgical masks and gowns do not go through. That is why we say "FDA 510(k) cleared".
Three products are FDA 510(k) cleared: the Myflon Surgical Mask Level 3 (K212111, cleared January 23, 2022), the Bodygard SFS Surgical Gown Level 3 (K202845, cleared February 24, 2022) and the Bodygard SFS Surgical Gown Level 4 (K221139, cleared November 10, 2022). Our coveralls, scrubs, drape packs and OR towels are not covered by these clearances.