Cleared Traditional

K072614 - MATANG BLACK

K072614 is the FDA 510(k) clearance for MATANG BLACK by Matang Mfg. Sdn. Bhd.. It is a Class 1 General Hospital device (product code LYY) cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K072614 · Matang Mfg. Sdn. Bhd. · General Hospital
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Apr 2008
Decision
211d
Days
Class 1
Risk

K072614 is an FDA 510(k) clearance for the MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Matang Mfg. Sdn. Bhd. (Jasin, Melaka, MY). The FDA issued a Cleared decision on April 15, 2008 after a review of 211 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - 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 Matang Mfg. Sdn. Bhd. devices

Submission Details

510(k) Number K072614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2007
Decision Date April 15, 2008
Days to Decision 211 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
82d slower than avg
Panel avg: 129d · This submission: 211d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes 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 - LYY Latex Patient Examination Glove

All 150
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K072614.
PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA
K100211 · Shen Wei (Usa), Inc. · May 2010
NON-STERILE, POWDERED LATEX EXAMINATION GLOVE
K081910 · Siam Sempermed Corp., Ltd. · Sep 2008
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 MICROGRAMS OR LESS)
K081907 · Siam Sempermed Corp., Ltd. · Sep 2008
STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 UG OR LESS)
K051329 · Siam Sempermed Corp., Ltd. · Jul 2005
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW)
K050277 · Hartalega Sdn Bhd · Jun 2005
DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI
K040645 · Wrp Asia Pacific Sdn. Bhd. · Apr 2004