BRIGHT ELEMENT SND BHD LATEX POWDER FREE EXAMINATION GLOVES— 510(k) K061078
Substantially EquivalentBright Element Sdn Bhd
FDA 510(k) clearance K061078 for BRIGHT ELEMENT SND BHD LATEX POWDER FREE EXAMINATION GLOVES, Substantially Equivalent on 2006-05-19. 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
- Klang Selangor Darul Ehsan, MY
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More clearances from Bright Element Sdn Bhd
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