Cleared Traditional

K011066 - STERILE LATEX SURGICAL GLOVES (POWDERED...

K011066 is an FDA 510(k) clearance for STERILE LATEX SURGICAL GLOVES (POWDERED..., manufactured by Smart Glove Corp. Sdn Bhd. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K011066 · Smart Glove Corp. Sdn Bhd · General Hospital
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Sep 2001
Decision
155d
Days
Class 1
Risk

K011066 is an FDA 510(k) clearance for the STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM .... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Smart Glove Corp. Sdn Bhd (Klang Selangor, MY). The FDA issued a Cleared decision on September 11, 2001 after a review of 155 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.

View all Smart Glove Corp. Sdn Bhd devices

FDA 510(k) Submission Details - K011066

510(k) Number K011066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2001
Decision Date September 11, 2001
Days to Decision 155 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
26d slower than avg
Panel avg: 129d · This submission: 155d
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 188
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K011066.
DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM
K013302 · Allegiance Healthcare Corp. · Dec 2001
STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G
K013727 · Smart Glove Corp. Sdn Bhd · Dec 2001
STERILE NITRILE SURGICAL GLOVES (POWDERED)
K012479 · Smart Glove Corp. Sdn Bhd · Sep 2001
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES
K011721 · Allegiance Healthcare Corp. · Aug 2001
POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K012135 · Wrp Asia Pacific Sdn. Bhd. · Aug 2001
ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WITH PROTEIN LABELING CLAIM, 50 PER GRAM OR LESS OF TOTAL WATER
K010862 · Allegiance Healthcare Corp. · Jun 2001