DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)— 510(k) K011482
Substantially EquivalentWrp Asia Pacific Sdn. Bhd.
FDA 510(k) clearance K011482 for DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS), Substantially Equivalent on 2001-07-09. 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
- Sepang, 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.