POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM— 510(k) K102189
Substantially EquivalentLatexx Manufacturing Sdn.Bhd.
FDA 510(k) clearance K102189 for POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM, Substantially Equivalent on 2012-03-14. Applicant: Latexx Manufacturing Sdn.Bhd.. Device class: 1.
Clearance details
- Applicant
- Latexx Manufacturing Sdn.Bhd.
- Product code
- Code LZC
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wheat Ridge, CO, US
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More clearances from Latexx Manufacturing Sdn.Bhd.
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- K022102 — CLEANTEXX POWDERFREE BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVES, BLUE COLOUR
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Data sourced from openFDA. This site is unofficial and independent of the FDA.