Cleared Traditional

K031670 - STERILE POWDER FREE LATEX SURGICAL GLOVE WITH POLYMER COATING

K031670 is an FDA 510(k) clearance for STERILE POWDER FREE LATEX SURGICAL GLOV..., manufactured by P.T. Saptindo Surgica. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K031670 · P.T. Saptindo Surgica · General Hospital
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Sep 2003
Decision
117d
Days
Class 1
Risk

K031670 is an FDA 510(k) clearance for the STERILE POWDER FREE LATEX 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

FDA 510(k) Submission Details - K031670

510(k) Number K031670 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.

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 335
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K031670.
PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE
K032942 · Wrp Asia Pacific Sdn. Bhd. · Dec 2003
ALOETOUCH POWDER FREE NEOPRENE SURGICAL GLOVES, STERILE, TURQUOISE COLOUR AND COATED WITH ALOE VERA
K032647 · Wrp Asia Pacific Sdn. Bhd. · Nov 2003
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING
K031301 · Cardinalhealth · Oct 2003
ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50
K032464 · Wrp Asia Pacific Sdn. Bhd. · Aug 2003
POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES
K030228 · Pt. Medisafe Technologies · Mar 2003
POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE
K024130 · Wrp Asia Pacific Sdn. Bhd. · Dec 2002