UNISEAL GLOVES LOW PROTEIN POWDERED
FDA 510(k) clearance K981979 · decided 1998-11-30
Clearance details
- K-number
- K981979
- Device name
- UNISEAL GLOVES LOW PROTEIN POWDERED
- Applicant
- American Healthcare Products (M) Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 1998-06-05
- Decision date
- 1998-11-30
- Days to decision
- 178 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Nilai, Negeri Sembilan 71800, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.