Cleared Traditional

K002593 - POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM

K002593 is an FDA 510(k) clearance for POWDER FREE STERILE LATEX SURGICAL GLOVES, manufactured by Hartalega Sdn Bhd. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K002593 · Hartalega Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
100d
Days
Class 1
Risk

K002593 is an FDA 510(k) clearance for the POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF T.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Hartalega Sdn Bhd (Kuala Lumpur, MY). The FDA issued a Cleared decision on November 29, 2000 after a review of 100 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 Hartalega Sdn Bhd devices

FDA 510(k) Submission Details - K002593

510(k) Number K002593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2000
Decision Date November 29, 2000
Days to Decision 100 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 129d · This submission: 100d
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 322
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K002593.
MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS)
K010438 · Terang Nusa Sdn Bhd · May 2001
MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS)
K010439 · Terang Nusa Sdn Bhd · May 2001
X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MICROGRAMS OR LESS, MODEL STYLE 21
K003895 · Ansell Perry · Jan 2001
PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE
K003019 · Wrp Asia Pacific Sdn. Bhd. · Nov 2000
STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES
K002933 · Maxxim Medical · Oct 2000
DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES
K002192 · Ansell Perry · Jul 2000