Zibo Shengkun Chemical Industry Co., Ltd. · Class I · Cleared Jul 7, 2025
| K-number | K250496 |
| Device name | Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) |
| Applicant | Zibo Shengkun Chemical Industry Co., Ltd. |
| Product code | LZA |
| Device class | Class I |
| Decision date | Jul 7, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 880.6250 |
The Powder Free Polyurethane Examination Gloves (available in green, blue, pink, and white) are disposable medical gloves intended to be worn on the examiner's hand or finger during patient examinations to prevent contamination between patient and examiner. The device is classified as a Class I non-powdered patient examination glove and is marked for over-the-counter use.
Not stated in this summary.
Not stated in this summary.
The FDA determined substantial equivalence by comparing this device to legally marketed predicate devices that were in interstate commerce prior to May 28, 1976, or to devices reclassified under the Federal Food, Drug, and Cosmetic Act. The device shares the same intended use (medical examination gloves for preventing contamination) and regulatory classification (Class I, non-powdered patient examination glove, product code LZA) as existing predicates, establishing substantial equivalence without requiring additional premarket approval.
View the full FDA submission: accessdata.fda.gov