PRE POWDERED LATEX EXAMINATION GLOVES
FDA 510(k) clearance K990879 · decided 1999-05-17
Clearance details
- K-number
- K990879
- Device name
- PRE POWDERED LATEX EXAMINATION GLOVES
- Applicant
- Apl Products Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 1999-03-16
- Decision date
- 1999-05-17
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Ayer Tawar,Perak Darul Ridzuan, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.