ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES— 510(k) K063776
Substantially EquivalentBright Element Sdn Bhd
FDA 510(k) clearance K063776 for ABLE GLOVE LATEX POWDERED EXAMINATION GLOVES, Substantially Equivalent on 2007-03-02. Applicant: Bright Element Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Bright Element 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
- Subang Jaya, Selangor, MY
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More clearances from Bright Element Sdn Bhd
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