MEDTEXX POWDERFREE NITRILE RUBBER EXAMINATION GLOVES, GREEN COLOUR— 510(k) K022101
Substantially EquivalentLatexx Manufacturing Sdn.Bhd.
FDA 510(k) clearance K022101 for MEDTEXX POWDERFREE NITRILE RUBBER EXAMINATION GLOVES, GREEN COLOUR, Substantially Equivalent on 2002-08-02. Applicant: Latexx Manufacturing Sdn.Bhd.. Device class: 1.
Clearance details
- Applicant
- Latexx 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
- Hackensack, NJ, US
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More clearances from Latexx Manufacturing Sdn.Bhd.
view all- K102189 — POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM
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- K034052 — BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
- K022346 — CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOLYMER EXAMINATION GLOVES
- K022102 — CLEANTEXX POWDERFREE BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVES, BLUE COLOUR
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.