Cleared Traditional

K984020 - POWDERED LATEX EXAMINATION GLOVE WITH P...

K984020 is the FDA 510(k) clearance for POWDERED LATEX EXAMINATION GLOVE WITH P... by Kossan Latex Industries(M)Sdn Bhd. It is a Class 1 General Hospital device (product code LYY) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K984020 · Kossan Latex Industries(M)Sdn Bhd · General Hospital
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Dec 1998
Decision
41d
Days
Class 1
Risk

K984020 is an FDA 510(k) clearance for the POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (150 MIC.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Kossan Latex Industries(M)Sdn Bhd (Klang, Selangor, MY). The FDA issued a Cleared decision on December 23, 1998 after a review of 41 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kossan Latex Industries(M)Sdn Bhd devices

Submission Details

510(k) Number K984020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1998
Decision Date December 23, 1998
Days to Decision 41 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
88d faster than avg
Panel avg: 129d · This submission: 41d
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 K984020.
ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
K972616 · Wembley Rubber Products (M) Sdn Bhd · Jan 1999
CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
K972615 · Wembley Rubber Products (M) Sdn Bhd · Jan 1999
TEXTURED POWDER-FREE LATEX EXAM GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K983145 · Shen Wei (Usa), Inc. · Jan 1999
LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED
K981975 · Siam Sempermed Corp., Ltd. · Nov 1998
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN)
K980572 · Hartalega Sdn Bhd · Mar 1998
POWDER-FREE LATEX EXAMINATION GLOVES (BLUE)
K980318 · Hartalega Sdn Bhd · Mar 1998