Cleared Traditional

STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING (K031669) - FDA 510(k) Clearance

Class I General Hospital device.

K031669 · P.T. Saptindo Surgica · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
117d
Days
Class 1
Risk

K031669 is an FDA 510(k) clearance for the STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by P.T. Saptindo Surgica (Serang-Banten, ID). The FDA issued a Cleared decision on September 23, 2003 after a review of 117 days - within the typical 510(k) review window.

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.

View all P.T. Saptindo Surgica devices

Submission Details

510(k) Number K031669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2003
Decision Date September 23, 2003
Days to Decision 117 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 129d · This submission: 117d
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 K031669.
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