BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE— 510(k) K053441

Name: FDA 510(k) clearance K053441
Creator: U.S. Food and Drug Administration
Published: 2006-04-10

Substantially Equivalent

Regent Medical Americas, LLC

FDA 510(k) clearance K053441 for BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE, Substantially Equivalent on 2006-04-10. Applicant: Regent Medical Americas, LLC. Device class: 1.

Clearance details

Applicant: Regent Medical Americas, LLC
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2005-12-09
Decision date: 2006-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KGO

view all

K260558 — Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate +1 more2026-07-28
K253060 — Sterile Latex Powder Free Surgical Gloves2026-05-22
K250313 — Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid2025-08-19
K240790 — Polyisoprene Surgical gloves2024-08-23
K232079 — Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green) +1 more2024-03-28

More clearances from Regent Medical Americas, LLC

view all

K053102 — BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE2006-03-10
K053442 — BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE2006-03-07
K053443 — BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE2006-02-01
K050899 — BIOGEL LATEX STERILE POWDER-FREE GLOVE2005-08-12
K050533 — ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVE2005-04-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.