Cleared Traditional

K052177 - POWDER FREE STERILE LATEX SURGICAL GLOVES

K052177 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 121-day FDA review.

K052177 · Hartalega Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
121d
Days
Class 1
Risk

K052177 is an FDA 510(k) clearance for the POWDER FREE STERILE LATEX SURGICAL GLOVES. 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 9, 2005 after a review of 121 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 - K052177

510(k) Number K052177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2005
Decision Date December 09, 2005
Days to Decision 121 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
8d faster than avg
Panel avg: 129d · This submission: 121d
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 K052177.
POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE)
K062950 · Hartalega Sdn Bhd · Dec 2006
BIOGEL ECLIPSE INDICATOR UNDERGLOVE
K062847 · Molnlycke Health Care Us, LLC · Dec 2006
CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES
K053272 · Cardinalhealth · Jan 2006
SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA
K052837 · Terang Nusa Sdn Bhd · Nov 2005
NUZONE SYNGARD POWDER FREE POLYMER COATED POLYISOPRENE STERILE SURGICAL GLOVE - ALOE VERA COATED GREEN COLOUR
K051562 · Terang Nusa Sdn Bhd · Oct 2005
ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE)
K051793 · Ansell Healthcare Products, LLC · Aug 2005