Dental Barrier and Sleeves

Dental Barrier and Sleeves are disposable polyethylene covers designed to protect dental instruments and equipment from contamination. The device covers various hand-held instruments (handpieces, curing lights, syringes, mirrors, scalers, cameras) and larger equipment (dental chairs, trays, x-ray heads). It is non-sterile and intended for single-patient use only.

The device is made from polyethylene film (LLDPE 80%, LDPE 20%) with film thickness of 0.02–0.06 mm and tolerance <0.01 mm. Some models include paper backing. Material composition is identical to the predicate device; minor differences exist in specifications (predicate had no paper backing and fixed 0.025 mm thickness) but do not affect safety or effectiveness.

ASTM F1670 (synthetic blood penetration), ASTM F1671 (viral penetration), ASTM D882 (tensile properties), ASTM F1342 (tear resistance), ASTM D1004 (puncture resistance). Biocompatibility testing per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), and ISO 10993-23 (irritation). X-ray effectiveness testing confirmed the device does not impair x-ray device function.

The subject device has identical intended use, material composition, performance characteristics, and labeling as the predicate (K233918). Both are single-use, non-sterile polyethylene barrier sleeves with the same dimensional ranges, physical properties (penetration and tear resistance), and biocompatibility profile. Minor differences in specifications and tolerances (paper backing presence, thickness tolerance) do not raise questions of safety or effectiveness because they reflect design flexibility for different equipment sizes, not fundamental design changes.