K231902
- 510(k) number
- K231902
- Device name
- GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)
- Applicant
- Ansell Healthcare NV · US
- Product code
- KGO — Surgeon'S Gloves
- Decision date
- 2023-10-20
- Date received
- 2023-06-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K231902.pdf
Official FDA record: K231902
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.