DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U
FDA 510(k) clearance K111139 · decided 2011-09-02
Clearance details
- K-number
- K111139
- Device name
- DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U
- Applicant
- Ansell Healthcare Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-04-22
- Decision date
- 2011-09-02
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- KGO
- Device class
- 1
- Regulation number
- 878.4460
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Lakewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290 recall (Z-0096-2024) | Ansell Healthcare Products LLC | 2023-10-11 |
| NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290 recall (Z-0097-2024) | Ansell Healthcare Products LLC | 2023-10-11 |