Cleared Traditional

K101103 - POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1

K101103 is an FDA 510(k) clearance for POWDERED, manufactured by Best Putra Gloves Sdn Bhd. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K101103 · Best Putra Gloves Sdn Bhd · General Hospital
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Jul 2010
Decision
87d
Days
Class 1
Risk

K101103 is an FDA 510(k) clearance for the POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Best Putra Gloves Sdn Bhd (Sg Choh Rawang, Selangor, MY). The FDA issued a Cleared decision on July 16, 2010 after a review of 87 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 Best Putra Gloves Sdn Bhd devices

FDA 510(k) Submission Details - K101103

510(k) Number K101103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2010
Decision Date July 16, 2010
Days to Decision 87 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
42d faster than avg
Panel avg: 129d · This submission: 87d
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 283
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K101103.
STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING
K102500 · Cardinal Health, Inc. · Nov 2010
PROTEGRITY SMT LATEX SURGICALGLOVES
K101811 · Cardinal Health, Inc. · Oct 2010
SUR-G GLOV AND MAXITEX
K102119 · Terang Nusa Sdn Bhd · Aug 2010
ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES
K093300 · Cardinal Health, Inc. · Oct 2009
ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES
K092304 · Cardinal Health, Inc. · Sep 2009
SKINSENSE POLYISOPRENE UNDERGLOVE
K081180 · Molnlycke Health Care Us, LLC · Aug 2008