TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O
FDA 510(k) clearance K122788 · decided 2013-01-17
Clearance details
- K-number
- K122788
- Device name
- TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O
- Applicant
- Northstar Healthcare Holdings
- Decision
- Substantially Equivalent
- Date received
- 2012-09-11
- Decision date
- 2013-01-17
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Dublin 2, IE
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.