Cleared Traditional

K123126 - MOTEX POLYISOPRENE POWDER-FREE SURGICAL...

K123126 is an FDA 510(k) clearance for MOTEX POLYISOPRENE POWDER-FREE SURGICAL..., manufactured by Shanghai Motex Healthcare Co., Ltd.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 608-day FDA review.

K123126 · Shanghai Motex Healthcare Co., Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Jun 2014
Decision
608d
Days
Class 1
Risk

K123126 is an FDA 510(k) clearance for the MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Shanghai Motex Healthcare Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on June 4, 2014 after a review of 608 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. 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.

View all Shanghai Motex Healthcare Co., Ltd. devices

FDA 510(k) Submission Details - K123126

510(k) Number K123126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2012
Decision Date June 04, 2014
Days to Decision 608 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
479d slower than avg
Panel avg: 129d · This submission: 608d
Pathway characteristics
Predicate-based equivalence.

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 252
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K123126.
BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES
K140477 · Molnlycke Health Care Us, LLC · Mar 2015
SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM
K140355 · Terang Nusa Sdn Bhd · Nov 2014
BIOGEL PL MICRO SURGICAL GLOVE
K141719 · Molnlycke Health Care Us, LLC · Sep 2014
PROTEXIS LATEX BASIC STERILE POWDER-FREE SURGICAL GLOVES
K121897 · Cardinal Health, Inc. · Jul 2012
PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS
K120934 · Cardinal Health, Inc. · May 2012
POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM
K113233 · Shen Wei (Usa), Inc. · Mar 2012