POWDERED LATEX SURGEON'S GLOVE— 510(k) K121925

Name: FDA 510(k) clearance K121925
Creator: U.S. Food and Drug Administration
Published: 2013-08-28

Substantially Equivalent

Suzhou Colour-Way Enterprise Development Co., Ltd.

FDA 510(k) clearance K121925 for POWDERED LATEX SURGEON'S GLOVE, Substantially Equivalent on 2013-08-28. Applicant: Suzhou Colour-Way Enterprise Development Co., Ltd.. Device class: 1.

Clearance details

Applicant: Suzhou Colour-Way Enterprise Development Co., Ltd.
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 2012-07-02
Decision date: 2013-08-28
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Suzhou, Jiangsu, CN

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 Suzhou Colour-Way Enterprise Development Co., Ltd.

view all

K083817 — M. DIOR BRAND2009-09-16

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