Basic Medical Technology, Inc. · Class I · Cleared Apr 7, 2026
| K-number | K260860 |
| Device name | Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) |
| Applicant | Basic Medical Technology, Inc. |
| Product code | LYZ |
| Device class | Class I |
| Decision date | Apr 7, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 880.6250 |
This is a powder-free, disposable synthetic vinyl examination glove available in black and blue colors, sizes S through XL. It is worn on the examiner's hand during medical examinations to prevent contamination between patient and examiner.
The subject device is virtually identical to the predicate device in material (vinyl), powder-free status, ambidextrous design, dimensions, thickness, and physical properties (tensile strength ≥11 MPa, ultimate elongation ≥300%). The only difference is color: the subject device is offered in black/blue whereas the predicate includes black/blue/purple. All biocompatibility testing was performed on the subject device colors.
ASTM D5250-19 (vinyl glove specification), ASTM D5151-19 (hole detection), ASTM D6124-06 (residual powder), ASTM D412-16 (elongation), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (skin sensitization), ISO 10993-23:2021 (skin irritation).
The subject device is substantially equivalent to predicate K220992 because it shares identical indications for use, product code (LYZ), regulation (21 CFR 880.6250), material composition, design, dimensions, and performance specifications. Non-clinical and biocompatibility testing demonstrate equivalent or superior safety and effectiveness. The color difference (removal of purple) does not affect functionality or performance.
View the full FDA submission: accessdata.fda.gov