K231973
- 510(k) number
- K231973
- Device name
- PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove
- Applicant
- Ineo Tech Sdn Bhd MY
- Product code
- KGO — Surgeon'S Gloves
- Decision date
- 2023-09-29
- Date received
- 2023-07-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K231973.pdf
Official FDA record: K231973
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.