POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR)
FDA 510(k) clearance K063524 · decided 2007-01-23
Clearance details
- K-number
- K063524
- Device name
- POWDER FREE NITRILE EXAMINATION GLOVES (WHITE AND BLUE COLOR)
- Applicant
- Hl Rubber Industries Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 2006-11-22
- Decision date
- 2007-01-23
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Kuala Pilah, Negeri Sembilan, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.