MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE WHITE COLOR, EXAMINATION GLOVES (INTACTA POLYURETHANE G— 510(k) K031384
Substantially EquivalentYty Industry (Manjung) Sdn Bhd
FDA 510(k) clearance K031384 for MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE WHITE COLOR, EXAMINATION GLOVES (INTACTA POLYURETHANE G, Substantially Equivalent on 2003-06-17. Applicant: Yty Industry (Manjung) Sdn Bhd.
Clearance details
- Applicant
- Yty Industry (Manjung) Sdn Bhd
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sparks, NV, 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.