Cleared Traditional

K062950 - POWDER FREE STERILE NITRILE SURGICAL GL...

K062950 is the FDA 510(k) clearance for POWDER FREE STERILE NITRILE SURGICAL GL... by Hartalega Sdn Bhd. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K062950 · Hartalega Sdn Bhd · General Hospital
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Dec 2006
Decision
83d
Days
Class 1
Risk

K062950 is an FDA 510(k) clearance for the POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE). 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 December 21, 2006 after a review of 83 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 Hartalega Sdn Bhd devices

Submission Details

510(k) Number K062950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2006
Decision Date December 21, 2006
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 143
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K062950.
MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM...
K111807 · Medline Industries, Inc. · Aug 2011
SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE
K102177 · Medline Industries, Inc. · Jun 2011
ZIMMER CUT RESISTANT GLOVE LINER, XSMALL, SMALL, MEDIUM, LARGE, XLARGE
K063582 · Zimmer, Inc. · Apr 2007
POWDER FREE STERILE LATEX SURGICAL GLOVES
K052177 · Hartalega Sdn Bhd · Dec 2005
DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM
K013302 · Allegiance Healthcare Corp. · Dec 2001
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES
K011721 · Allegiance Healthcare Corp. · Aug 2001