ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES— 510(k) K092304
Substantially EquivalentCardinal Health, Inc.
FDA 510(k) clearance K092304 for ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES, Substantially Equivalent on 2009-09-15. 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.