SUPERGLOVES
FDA 510(k) clearance K920058 · decided 1992-05-14
Clearance details
- K-number
- K920058
- Device name
- SUPERGLOVES
- Applicant
- Sempermed Glove Industries Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 1992-01-06
- Decision date
- 1992-05-14
- Days to decision
- 129 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Sungai Buloh, Selangor, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.