BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES— 510(k) K081972
Substantially EquivalentNitritex (M) Sdn. Bhd.
FDA 510(k) clearance K081972 for BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES, Substantially Equivalent on 2008-12-11. Applicant: Nitritex (M) Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Nitritex (M) Sdn. Bhd.
- Product code
- 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
- Kuala Langat, Selangor De, MY
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More clearances from Nitritex (M) 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.