CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREEN
FDA 510(k) clearance K011231 · decided 2001-06-13
Clearance details
- K-number
- K011231
- Device name
- CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREEN
- Applicant
- Protection Gloves Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2001-04-23
- Decision date
- 2001-06-13
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Chaah, Johor, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.