NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE)— 510(k) K980729
Substantially EquivalentPt. Eka Wira Asia
FDA 510(k) clearance K980729 for NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE), Substantially Equivalent on 1998-04-02. Applicant: Pt. Eka Wira Asia.
Clearance details
- Applicant
- Pt. Eka Wira Asia
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Fe Springs, CA, US
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.