ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE COLOR WITH CITRIC SCENT AND PINK COLOR
FDA 510(k) clearance K083571 · decided 2009-08-13
Clearance details
- K-number
- K083571
- Device name
- ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE COLOR WITH CITRIC SCENT AND PINK COLOR
- Applicant
- Purna Bina Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 2008-12-03
- Decision date
- 2009-08-13
- Days to decision
- 253 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Kluang, Johor, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.