ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR
FDA 510(k) clearance K012714 · decided 2001-10-31
Clearance details
- K-number
- K012714
- Device name
- ROYAL IMPERIAL POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR
- Applicant
- Koon Seng Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 2001-08-14
- Decision date
- 2001-10-31
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Muar, Johor, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.