MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS
FDA 510(k) clearance K103406 · decided 2010-12-23
Clearance details
- K-number
- K103406
- Device name
- MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS
- Applicant
- Kimberly-Clark Corp.
- Decision
- Substantially Equivalent
- Date received
- 2010-11-19
- Decision date
- 2010-12-23
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- FYA
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Roswell, GA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use recall (Z-0257-2013) | Kimberly-Clark Corporation | 2012-11-07 |
| MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile, s recall (Z-0258-2013) | Kimberly-Clark Corporation | 2012-11-07 |