ENCORE POWDER-FREE LATEX SURGICAL GLOVES, ORTHOPAEDIC WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)— 510(k) K003771
Substantially EquivalentAnsell Healthcare Products, Inc.
FDA 510(k) clearance K003771 for ENCORE POWDER-FREE LATEX SURGICAL GLOVES, ORTHOPAEDIC WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS), Substantially Equivalent on 2001-01-16. 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
- Special
- Location
- Massillon, OH, US
Recent devices under product code KGO
view all- K260558 — Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate +1 more
- K253060 — Sterile Latex Powder Free Surgical Gloves
- K250313 — Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid
- K240790 — Polyisoprene Surgical gloves
- K232079 — Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green) +1 more
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)
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.