ABLE GLOVE, NITRILE BLUE POWDERED EXAMINATION GLOVES
FDA 510(k) clearance K061074 · decided 2006-05-24
Clearance details
- K-number
- K061074
- Device name
- ABLE GLOVE, NITRILE BLUE POWDERED EXAMINATION GLOVES
- Applicant
- Bright Element Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 2006-04-17
- Decision date
- 2006-05-24
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Klang Selangor Darul Ehsan, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.