K233182
- 510(k) number
- K233182
- Device name
- Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)
- Applicant
- Zibo Kaiyue Mould Technology Co., Ltd. CN
- Product code
- LZA — Polymer Patient Examination Glove
- Decision date
- 2023-12-15
- Date received
- 2023-09-28
- 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: K233182
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.