POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS— 510(k) K101828
Substantially EquivalentGx Corporation Sdn Bhd
FDA 510(k) clearance K101828 for POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS, Substantially Equivalent on 2010-10-04. Applicant: Gx Corporation Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Gx Corporation Sdn Bhd
- Product code
- Code LYY
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Klang, Selangor, MY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.