Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)— 510(k) K250496

Substantially Equivalent

Zibo Shengkun Chemical Industry Co., Ltd.

FDA 510(k) clearance K250496 for Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White), Substantially Equivalent on 2025-07-07. Applicant: Zibo Shengkun Chemical Industry Co., Ltd..

Clearance details

Applicant
Zibo Shengkun Chemical Industry Co., Ltd.
Product code
Code LZA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Zibo, CN
Download summary PDFView on FDA.gov ↗

Adverse events under product code LZA

product code LZA
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.