K232614
- 510(k) number
- K232614
- Device name
- Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue)
- Applicant
- Sri Trang Gloves (Thailand) Public Company Limited TH
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2024-05-13
- Date received
- 2023-08-28
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- 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: K232614
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.