DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U— 510(k) K111139
Substantially EquivalentAnsell Healthcare Products, Inc.
FDA 510(k) clearance K111139 for DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U, Substantially Equivalent on 2011-09-02. Applicant: Ansell Healthcare Products, Inc.. Device class: 1.
Clearance details
- Applicant
- Ansell Healthcare Products, Inc.
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lakewood, CO, US
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More clearances from Ansell Healthcare Products, Inc.
view all- K082457 — MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)
- K042817 — MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)
- K023153 — MICRO-TOUCH NEXT STEP POWDER FREE MEDICAL EXAMINATION GLOVES WITH ALOE AND GLYCEROL
- K013603 — MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL STYLE 65
- K013604 — MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES
Recalls naming K111139
K-number listed on FDA's recall record- Z-0096-2024 — GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290
- Z-0097-2024 — NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290
- Z-0838-2022 — Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111139.
Data sourced from openFDA. This site is unofficial and independent of the FDA.