K240790
- 510(k) number
- K240790
- Device name
- Polyisoprene Surgical gloves
- Applicant
- Suzhou Colour-Way New Material Co., Ltd. CN
- Product code
- KGO — Surgeon'S Gloves
- Decision date
- 2024-08-23
- Date received
- 2024-03-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K240790
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.