Cleared Traditional

K896094 - LATEX EXAMINATION GLOVES

K896094 is an FDA 510(k) clearance for LATEX EXAMINATION GLOVES, manufactured by Matang Mfg. Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K896094 · Matang Mfg. Sdn. Bhd. · General Hospital
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Jan 1990
Decision
89d
Days
Class 1
Risk

K896094 is an FDA 510(k) clearance for the LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Matang Mfg. Sdn. Bhd. (Bahru Johor Darul Takzim, MY). The FDA issued a Cleared decision on January 17, 1990 after a review of 89 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 Matang Mfg. Sdn. Bhd. devices

FDA 510(k) Submission Details - K896094

510(k) Number K896094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1989
Decision Date January 17, 1990
Days to Decision 89 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 129d · This submission: 89d
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 632
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K896094.
UMI BRAIDED CATHETER CONNECTOR
K897128 · Universal Medical Instrument Corp. · Mar 1990
POWDER-FREE VINYL EXAMINATION GLOVES
K894686 · Dynarex Corp. · Jan 1990
CLP ELEVATED LIPID CONTROL
K895858 · Creative Laboratory Products, Inc. · Jan 1990
ANSELL DENTA GLOVES
K895660 · Ansell, Inc. · Jan 1990
STERILE EXAMINATION GLOVES, HYPO-ALLERGENIC'
K895807 · Safeskin Corp. · Dec 1989
STRAWBERRY SCENTED LATEX EXAMINATION GLOVES
K896135 · Arista Latindo Industrial Ltd. P.T · Dec 1989