POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE)— 510(k) K050598
Substantially EquivalentSmart Glove Corp. Sdn Bhd
FDA 510(k) clearance K050598 for POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE), Substantially Equivalent on 2005-04-07. Applicant: Smart Glove Corp. Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Smart Glove Corp. Sdn Bhd
- Product code
- Product code LZA
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Klang Selangor, MY
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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.