NITRILE EXAMINATION GLOVES, PRE-POWDERED
FDA 510(k) clearance K023979 · decided 2003-01-24
Clearance details
- K-number
- K023979
- Device name
- NITRILE EXAMINATION GLOVES, PRE-POWDERED
- Applicant
- Starmatrix Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 2002-12-02
- Decision date
- 2003-01-24
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Petaling Jaya, Selangor, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.