DERMAGRIP POWDER FREE GREEN POLYMER COATED EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE
FDA 510(k) clearance K003309 · decided 2000-11-22
Clearance details
- K-number
- K003309
- Device name
- DERMAGRIP POWDER FREE GREEN POLYMER COATED EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE
- Applicant
- Wrp Specialty Products Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2000-10-23
- Decision date
- 2000-11-22
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Selangor Daurl Ehsan, Sepang, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.