K252117
- 510(k) number
- K252117
- Device name
- Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution
- Applicant
- Sw Technologies, Inc. CA · US
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2026-06-24
- Date received
- 2025-07-07
- Decision
- Substantially Equivalent
- Clearance type
- Special
- 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: K252117
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.