POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS— 510(k) K091643
Substantially EquivalentGx Corporation Sdn Bhd
FDA 510(k) clearance K091643 for POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, Substantially Equivalent on 2009-11-02. Applicant: Gx Corporation Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Gx Corporation 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
- Klang, Selang Darul Ehsan, MY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.