GH GLOVES (POWERED)
FDA 510(k) clearance K934047 · decided 1993-12-22
Clearance details
- K-number
- K934047
- Device name
- GH GLOVES (POWERED)
- Applicant
- Grafik Hersteller Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 1993-08-19
- Decision date
- 1993-12-22
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Selangor Darul Ehsan, Malaysia, ML
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.