BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE
FDA 510(k) clearance K112257 · decided 2011-09-20
Clearance details
- K-number
- K112257
- Device name
- BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE
- Applicant
- Molnlycke Health Care Us, LLC
- Decision
- Substantially Equivalent
- Date received
- 2011-08-05
- Decision date
- 2011-09-20
- Days to decision
- 46 days
- Clearance type
- Special
- Product code
- KGO
- Device class
- 1
- Regulation number
- 878.4460
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Norcross, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.