ULTRAFREE THICK STERILE LATEX POWDER-FREE SURGICAL GLOVES— 510(k) K991992

Name: FDA 510(k) clearance K991992
Creator: U.S. Food and Drug Administration
Published: 1999-07-13

Substantially Equivalent

Allegiance Healthcare Corp.

FDA 510(k) clearance K991992 for ULTRAFREE THICK STERILE LATEX POWDER-FREE SURGICAL GLOVES, Substantially Equivalent on 1999-07-13. Applicant: Allegiance Healthcare Corp.. Device class: 1.

Clearance details

Applicant: Allegiance Healthcare Corp.
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 1999-06-14
Decision date: 1999-07-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Mcgraw Park, IL, 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 Allegiance Healthcare Corp.

view all

K023673 — AIRLIFE DEMAND NASAL CANNULA2003-05-02
K023419 — TRILAMINATE DRAPES/TIBURON2003-02-11
K024120 — MODIFICATION TO TEMNO BIOPSY NEEDLES2003-01-15
K024292 — MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM2003-01-09
K024102 — DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM2002-12-18

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