NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM— 510(k) K112976
Substantially EquivalentHartalega Snd. Bhd.
FDA 510(k) clearance K112976 for NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM, Substantially Equivalent on 2012-02-02. Applicant: Hartalega Snd. Bhd.. Device class: 1.
Clearance details
- Applicant
- Hartalega Snd. 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
- Bestari Jaya, MY
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More clearances from Hartalega Snd. 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.