Cleared Traditional

K013727 - STERILE POWDER FREE LATEX SURGICAL GLOV...

K013727 is an FDA 510(k) clearance for STERILE POWDER FREE LATEX SURGICAL GLOV..., 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 28-day FDA review.

K013727 · Smart Glove Corp. Sdn Bhd · General Hospital
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Dec 2001
Decision
28d
Days
Class 1
Risk

K013727 is an FDA 510(k) clearance for the STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G. 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 December 7, 2001 after a review of 28 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Smart Glove Corp. Sdn Bhd devices

FDA 510(k) Submission Details - K013727

510(k) Number K013727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2001
Decision Date December 07, 2001
Days to Decision 28 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
101d faster than avg
Panel avg: 129d · This submission: 28d
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 K013727.
POWDERED LATEX SURGIACAL GLOVES, STEERILE WITH EXPIRATION DATE LABELING CLAIM
K021159 · Wrp Asia Pacific Sdn. Bhd. · Jul 2002
POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)
K020019 · Wrp Asia Pacific Sdn. Bhd. · Jan 2002
DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM
K013302 · Allegiance Healthcare Corp. · Dec 2001
STERILE NITRILE SURGICAL GLOVES (POWDERED)
K012479 · Smart Glove Corp. Sdn Bhd · Sep 2001
STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
K011066 · Smart Glove Corp. Sdn Bhd · Sep 2001
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES
K011721 · Allegiance Healthcare Corp. · Aug 2001