STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING— 510(k) K111015
Substantially EquivalentCardinal Health, Inc.
FDA 510(k) clearance K111015 for STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING, Substantially Equivalent on 2011-05-06. Applicant: Cardinal Health, Inc.. Device class: 1.
Clearance details
- Applicant
- Cardinal Health, 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
- Waukegan, IL, 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 Cardinal Health, Inc.
view all- K170198 — Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)
- K160411 — Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating
- K160875 — Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating
- K153316 — Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)
- K122696 — POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE)
Data sourced from openFDA. This site is unofficial and independent of the FDA.