K250193
- 510(k) number
- K250193
- Device name
- Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)
- Applicant
- Basic Medical Technology, Inc. CA · US
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2025-07-09
- Date received
- 2025-01-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K250193
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.