Cleared Special

K052837 - SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA

K052837 is an FDA 510(k) clearance for SENSIFLEX PLUS POLYMER COATED LATEX POW..., manufactured by Terang Nusa Sdn Bhd. The device is a Class 1 General Hospital device with product code KGO cleared through the Special 510(k) pathway after a 46-day FDA review.

K052837 · Terang Nusa Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
46d
Days
Class 1
Risk

K052837 is an FDA 510(k) clearance for the SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Terang Nusa Sdn Bhd (Kota Bharu, Kelantan, MY). The FDA issued a Cleared decision on November 21, 2005 after a review of 46 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K052837

510(k) Number K052837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2005
Decision Date November 21, 2005
Days to Decision 46 days
Submission Type Special
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
83d faster than avg
Panel avg: 129d · This submission: 46d
Pathway characteristics
Modification to existing cleared device.

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 559
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K052837.
CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES
K053272 · Cardinalhealth · Jan 2006
BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE ORTHOPEDIC SURGICAL GLOVES
K052772 · Barriermed Glove Co. · Dec 2005
POWDER FREE STERILE LATEX SURGICAL GLOVES
K052177 · Hartalega Sdn Bhd · Dec 2005
NUZONE SYNGARD POWDER FREE POLYMER COATED POLYISOPRENE STERILE SURGICAL GLOVE - ALOE VERA COATED GREEN COLOUR
K051562 · Terang Nusa Sdn Bhd · Oct 2005
SURGEON'S GLOVE, POWDER FREE
K052030 · Shun Thai Rubber Gloves Industry Public Co., Ltd. · Sep 2005
POWDERED LATEX SURGEON'S GLOVE
K052031 · Shun Thai Rubber Gloves Industry Public Co., Ltd. · Sep 2005
K052837 · SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA
Download PDF Terang Nusa Sdn Bhd