POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, WHITE)
FDA 510(k) clearance K071119 · decided 2007-07-24
Clearance details
- K-number
- K071119
- Device name
- POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE, WHITE)
- Applicant
- Gx Corporation Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 2007-04-20
- Decision date
- 2007-07-24
- Days to decision
- 95 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, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.