Cleared Traditional

K130301 - LATEX SURGEON'S GLOVES (POWDERED AND POWDER FREE)

K130301 is an FDA 510(k) clearance for LATEX SURGEON'S GLOVES (POWDERED AND PO..., manufactured by Elimedical Devices (Fujian), Inc.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K130301 · Elimedical Devices (Fujian), Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
196d
Days
Class 1
Risk

K130301 is an FDA 510(k) clearance for the LATEX SURGEON'S GLOVES (POWDERED AND POWDER FREE). Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Elimedical Devices (Fujian), Inc. (Shanghai, CN). The FDA issued a Cleared decision on August 22, 2013 after a review of 196 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K130301

510(k) Number K130301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2013
Decision Date August 22, 2013
Days to Decision 196 days
Submission Type Traditional
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
67d slower than avg
Panel avg: 129d · This submission: 196d
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 439
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K130301.
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
POWDERED LATEX SURGEON'S GLOVE
K121925 · Suzhou Colour-Way Enterprise Development Co., Ltd. · Aug 2013
FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES
K123629 · Lucenxia Prescience AG · May 2013
STERILE LATEX SURGICAL GLOVE
K123628 · Lucenxia Prescience AG · Mar 2013
G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE
K121335 · Hutchinson Sante S.N.C. · Sep 2012