POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM
FDA 510(k) clearance K082302 · decided 2008-12-09
Clearance details
- K-number
- K082302
- Device name
- POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM
- Applicant
- Pt. Medisafe Technologies
- Decision
- Substantially Equivalent
- Date received
- 2008-08-12
- Decision date
- 2008-12-09
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Medan, North Sumatra, ID
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.