Basic Medical Technology, Inc. · Class I · Cleared Aug 28, 2025
| K-number | K252505 |
| Device name | Powder-Free Vinyl Exam Gloves, clear |
| Applicant | Basic Medical Technology, Inc. |
| Product code | LYZ |
| Device class | Class I |
| Decision date | Aug 28, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 880.6250 |
Powder-Free Vinyl Exam Gloves, clear is a disposable, non-sterile medical examination glove made of vinyl material, available in sizes S, M, L, and XL. It is worn on the examiner's hand to prevent contamination between patient and examiner during medical procedures.
The device is identical to its predicate device (K220469) in all material and performance specifications: vinyl material, powder-free, ambidextrous design, clear color, same dimensions (230mm length with widths of 85-115mm by size), 0.08mm thickness, minimum 11 MPa tensile strength before and after aging, minimum 300% ultimate elongation, and meets ASTM D5151 hole-detection standards at AQL 2.5.
ISO 10993-5 (cytotoxicity), ISO 10993-10:2021 (sensitization), ISO 10993-23:2021 (irritation), ASTM D5250-19 (vinyl glove specification), ASTM D5151-19 (hole detection), ASTM D6124-06 (residual powder), ASTM D412-16 (physical properties), and ASTM D3767-03 (dimensions).
The subject device demonstrates substantial equivalence because it is identical in design, materials, dimensions, performance specifications, and regulatory classification to the predicate device K220469. Non-clinical testing shows equivalent biocompatibility results (non-sensitizing, non-irritating, non-cytotoxic) and all physical and mechanical properties meet or exceed the same acceptance criteria as the predicate. Both devices are Class I non-powdered patient examination gloves regulated under 21 CFR 880.6250 with identical product codes and indications for use.
View the full FDA submission: accessdata.fda.gov