Cleared Abbreviated

K121925 - POWDERED LATEX SURGEON'S GLOVE

K121925 is an FDA 510(k) clearance for POWDERED LATEX SURGEON'S GLOVE, manufactured by Suzhou Colour-Way Enterprise Development Co., Ltd.. The device is a Class 1 General Hospital device with product code KGO cleared through the Abbreviated 510(k) pathway after a 422-day FDA review.

K121925 · Suzhou Colour-Way Enterprise Development Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
422d
Days
Class 1
Risk

K121925 is an FDA 510(k) clearance for the POWDERED LATEX SURGEON'S GLOVE. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Suzhou Colour-Way Enterprise Development Co., Ltd. (Suzhou, Jiangsu, CN). The FDA issued a Cleared decision on August 28, 2013 after a review of 422 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

FDA 510(k) Submission Details - K121925

510(k) Number K121925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2012
Decision Date August 28, 2013
Days to Decision 422 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
293d slower than avg
Panel avg: 129d · This submission: 422d
Pathway characteristics
Standards-based clearance path.

KGO Device Classification - Class 1, General Controls

Product Code KGO Surgeon's Gloves
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4460
Definition A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KGO Surgeon's Gloves

All 437
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K121925.
MOTEX POWDERED NITRILE SURGICAL GLOVES
K132802 · Shanghai Motex Healthcare Co., Ltd. · May 2014
MOTEX POWDER-FREE NITRILE SURGICAL GLOVES
K122557 · Shanghai Motex Healthcare Co., Ltd. · Oct 2013
FINESSIS VIOLET ELEMENT POLYISOPRENE POWDERFREE STERILE SURGICAL GLOVES
K131751 · Lucenxia Prescience AG · Sep 2013
LATEX SURGEON'S GLOVES (POWDERED AND POWDER FREE)
K130301 · Elimedical Devices (Fujian), Inc. · Aug 2013
FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES
K123629 · Lucenxia Prescience AG · May 2013
STERILE LATEX SURGICAL GLOVE
K123628 · Lucenxia Prescience AG · Mar 2013