POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE
FDA 510(k) clearance K041913 · decided 2004-12-01
Clearance details
- K-number
- K041913
- Device name
- POWDERFREE COLORED AND FLAVORED CHLOREPRENE PATIENT EXAMINATION GLOVES TESTED FOR CHEMO USE
- Applicant
- Pt. Medisafe Technologies
- Decision
- Substantially Equivalent
- Date received
- 2004-07-15
- Decision date
- 2004-12-01
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Tanjung Morawa, Medan, ID
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.