Cleared Traditional

K896673 - LATEX PATIENT EXAMINATION GLOVES

K896673 is an FDA 510(k) clearance for LATEX PATIENT EXAMINATION GLOVES, manufactured by Alliance Rubber Products Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K896673 · Alliance Rubber Products Sdn. Bhd. · General Hospital
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Mar 1990
Decision
101d
Days
Class 1
Risk

K896673 is an FDA 510(k) clearance for the LATEX PATIENT EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Alliance Rubber Products Sdn. Bhd. (Malaysia, MY). The FDA issued a Cleared decision on March 8, 1990 after a review of 101 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K896673

510(k) Number K896673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1989
Decision Date March 08, 1990
Days to Decision 101 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 129d · This submission: 101d
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 1324
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K896673.
NON-STERILE LATEX PROCEDURE GLOVE
K900869 · Sri Johani Sdn. Bhd. · Mar 1990
PATIENT EXAMINATION GLOVES (LATEX)
K895941 · Gim'S Trading Corp. · Mar 1990
LATEX PATIENT EXAMINATION GLOVES
K896672 · U.O.P. Rubber Products Sdn Bhd · Mar 1990
P2/CHEMO PLUS GLOVES
K900368 · Biosafety Systems, Inc. · Mar 1990
LATEX PATIENT EXAMINATION GLOVES
K900499 · Premium Fit · Mar 1990
NIL STERILE LATEX EXAMINATION GLOVES
K900648 · United Lion Rubber Industries Sdn. Bhd. · Mar 1990
K896673 · LATEX PATIENT EXAMINATION GLOVES
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