Basic Medical Technology, Inc. · Class I · Cleared Jan 23, 2026
| K-number | K253160 |
| Device name | Syntex Exam Gloves |
| Applicant | Basic Medical Technology, Inc. |
| Product code | LZA |
| Device class | Class I |
| Decision date | Jan 23, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 880.6250 |
Syntex Exam Gloves are disposable, non-sterile, powder-free examination gloves made from synthetic butadiene-acrylonitrile latex. They are worn on the examiner's hand to prevent contamination between patient and examiner, available in sizes XS through XXL with a beaded cuff design for single use only.
The proposed device differs from the predicate (Synguard Nitrile Exam Glove) in color (natural latex vs. blue) and size range (XS-XXL vs. S-XL). Both are non-sterile, powder-free, ambidextrous nitrile gloves with identical thickness (minimum 0.05 mm), tensile strength (minimum 14 MPa), and biocompatibility profiles. The proposed device meets ASTM D6319-19 specifications for nitrile examination gloves.
ASTM D6319-19 (Nitrile Examination Gloves), ASTM D5151-19 (Detection of Holes), ASTM D6124-06 (Residual Powder), ASTM D412-16 (Tensile Properties), ISO 10993-10:2021 (Skin Sensitization), ISO 10993-23:2021 (Skin Irritation), and ISO 10993-11:2017 (Acute Systemic Toxicity).
The subject device is substantially equivalent to the predicate because both share the same regulatory classification (Class I, 21 CFR 880.6250), indications for use, material composition, and performance specifications. Non-clinical testing demonstrates the proposed device meets all design specifications and performance criteria identical to the predicate, with color and size differences that do not affect safety or effectiveness as both are covered by the same ASTM standard.
View the full FDA submission: accessdata.fda.gov