K232538
- 510(k) number
- K232538
- Device name
- DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL
- Applicant
- Wrp Asia Pacific Sdn. Bhd. MY
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2023-11-17
- Date received
- 2023-08-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K232538.pdf
Official FDA record: K232538
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.