THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE— 510(k) K162626
Substantially EquivalentTop Quality Glove Sdn. Bhd
FDA 510(k) clearance K162626 for THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE, Substantially Equivalent on 2017-03-31. Applicant: Top Quality Glove Sdn. Bhd.
Clearance details
- Applicant
- Top Quality Glove Sdn. Bhd
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Klang, MY
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.