FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES— 510(k) K123629
Substantially EquivalentLucenxia Prescience AG
FDA 510(k) clearance K123629 for FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES, Substantially Equivalent on 2013-05-13. Applicant: Lucenxia Prescience AG. Device class: 1.
Clearance details
- Applicant
- Lucenxia Prescience AG
- 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
- Baar, CH
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 Lucenxia Prescience AG
view all- K173304 — Finessis Intense Polyisoprene Surgical Glove
- K173386 — Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs
- K171987 — Finessis Zero Flexylon Powder Free Sterile White Surgical Glove
- K162852 — Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove
- K151605 — Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves
Data sourced from openFDA. This site is unofficial and independent of the FDA.