Cleared Traditional

K984229 - LATEX EXAMINATION GLOVES (POWDERED)

K984229 is an FDA 510(k) clearance for LATEX EXAMINATION GLOVES (POWDERED), manufactured by Sama Kejuruteraan Sdn.Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K984229 · Sama Kejuruteraan Sdn.Bhd. · General Hospital
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Optimized for regulatory review, auditing and printing
May 1999
Decision
173d
Days
Class 1
Risk

K984229 is an FDA 510(k) clearance for the LATEX EXAMINATION GLOVES (POWDERED). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Sama Kejuruteraan Sdn.Bhd. (Selangor D.E., MY). The FDA issued a Cleared decision on May 17, 1999 after a review of 173 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 Sama Kejuruteraan Sdn.Bhd. devices

FDA 510(k) Submission Details - K984229

510(k) Number K984229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1998
Decision Date May 17, 1999
Days to Decision 173 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
44d slower than avg
Panel avg: 129d · This submission: 173d
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 486
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K984229.
LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS)
K991686 · Arista Latindo Industrial Ltd. P.T · Jun 1999
SENSIFLEX POWDERFREE LATEX EXAMINATION GLOVE
K990488 · Terang Nusa Sdn Bhd · May 1999
POLYMER COATED POWDERFREE LATEX EXAMINTATION GLOVES
K990690 · Top Glove Sdn. Bhd. · May 1999
LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING
K990468 · Top Glove Sdn. Bhd. · Apr 1999
DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT LABELING)
K991044 · Wrp Specialty Products Sdn. Bhd. · Apr 1999
BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE)
K990539 · Brightway Holdings Sdn. Bhd. · Apr 1999