CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR)— 510(k) K123116
Substantially EquivalentWorldmed Manufacturing Sdn. Bhd.
FDA 510(k) clearance K123116 for CHLORINATED POWDER FREE NITRILE EXAMINATION GLOVES (BLACK COLOUR), Substantially Equivalent on 2013-02-11. Applicant: Worldmed Manufacturing Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Worldmed Manufacturing 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
- Kamunting, MY
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More clearances from Worldmed Manufacturing Sdn. Bhd.
view allAdverse 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.