K240930
- 510(k) number
- K240930
- Device name
- Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue; Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Blue
- Applicant
- Sri Trang Gloves Thailand (Public Company Limited) TH
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2024-07-02
- Date received
- 2024-04-04
- 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: K240930
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.