Cleared Traditional

POWDERED LATEX SURGEON'S GLOVES (K031368) - FDA 510(k) Clearance

Class I General Hospital device.

K031368 · Cephas Medical Private , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
419d
Days
Class 1
Risk

K031368 is an FDA 510(k) clearance for the POWDERED LATEX SURGEON'S GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Cephas Medical Private , Ltd. (Chennai Tamilnadu, IN). The FDA issued a Cleared decision on June 22, 2004 after a review of 419 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 Cephas Medical Private , Ltd. devices

Submission Details

510(k) Number K031368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2003
Decision Date June 22, 2004
Days to Decision 419 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
290d slower than avg
Panel avg: 129d · This submission: 419d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 97
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K031368.
MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM...
K111807 · Medline Industries, Inc. · Aug 2011
SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE
K102177 · Medline Industries, Inc. · Jun 2011
ZIMMER CUT RESISTANT GLOVE LINER, XSMALL, SMALL, MEDIUM, LARGE, XLARGE
K063582 · Zimmer, Inc. · Apr 2007
DURAPRENE STERILE SYNTHETIC SURGEON'S GLOVES
K941770 · Baxter Healthcare Corp · Jul 1994
SURESOFT SURGICAL GLOVES
K940218 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1994
DEXTREN(TM) POWDER FREE HYPOALLERGENIC GLOVES
K935869 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1994