K230681
- 510(k) number
- K230681
- Device name
- Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl
- Applicant
- Central Medicare Sdn Bhd MY
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2023-10-02
- Date received
- 2023-03-13
- 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: K230681
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.