K250496
- 510(k) number
- K250496
- Device name
- Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)
- Applicant
- Zibo Shengkun Chemical Industry Co., Ltd. CN
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2025-07-07
- Date received
- 2025-02-20
- 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: K250496
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.