Cleared Traditional

K974424 - COMFORT RUBBER GLOVES INDUSTRIES SDN BHD

K974424 is an FDA 510(k) clearance for COMFORT RUBBER GLOVES INDUSTRIES SDN BHD, manufactured by Comfort Rubber Gloves Industries Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K974424 · Comfort Rubber Gloves Industries Sdn. Bhd. · General Hospital
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Apr 1998
Decision
150d
Days
Class 1
Risk

K974424 is an FDA 510(k) clearance for the COMFORT RUBBER GLOVES INDUSTRIES SDN BHD. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Comfort Rubber Gloves Industries Sdn. Bhd. (Matang, MY). The FDA issued a Cleared decision on April 23, 1998 after a review of 150 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 Comfort Rubber Gloves Industries Sdn. Bhd. devices

FDA 510(k) Submission Details - K974424

510(k) Number K974424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1997
Decision Date April 23, 1998
Days to Decision 150 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
21d slower than avg
Panel avg: 129d · This submission: 150d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

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 265
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K974424.
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K980916 · Perusahaan Getah Asas Sdn. Bhd. · Aug 1998
SMARTTEX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM
K981347 · Smart Glove Corp. Sdn Bhd · May 1998
SMARTTEX PREPOWDERED LATEX EXAMINATION GLOVES
K981348 · Smart Glove Corp. Sdn Bhd · May 1998
SMARTTEX
K974557 · Smart Glove Corp. Sdn Bhd · Mar 1998
LATEX EXAMINATION GLOVE POWDER FREE
K974870 · Smart Glove Corp. Sdn Bhd · Mar 1998
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN)
K980572 · Hartalega Sdn Bhd · Mar 1998