COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)— 510(k) K001613
Substantially EquivalentWrp Asia Pacific Sdn. Bhd.
FDA 510(k) clearance K001613 for COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS), Substantially Equivalent on 2000-11-22. Applicant: Wrp Asia Pacific Sdn. Bhd..
Clearance details
- Applicant
- Wrp Asia Pacific Sdn. Bhd.
- Product code
- Code LZA
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salak Tinggi, Sepang Selangor, 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.