MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)— 510(k) K042817
Substantially EquivalentAnsell Healthcare Products, Inc.
FDA 510(k) clearance K042817 for MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE), Substantially Equivalent on 2004-12-06. Applicant: Ansell Healthcare Products, Inc.. Device class: 1.
Clearance details
- Applicant
- Ansell Healthcare Products, Inc.
- Product code
- Code LZA
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dothan, AL, US
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More clearances from Ansell Healthcare Products, Inc.
view all- K111139 — DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U
- K082457 — MICRO-TOUCH NITRATEX STERILE 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
Adverse events under product code LZA
product code LZA- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.