NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE
FDA 510(k) clearance K003545 · decided 2000-12-21
Clearance details
- K-number
- K003545
- Device name
- NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE
- Applicant
- Terang Nusa Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 2000-11-17
- Decision date
- 2000-12-21
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Kota Bharu, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.