Cleared Traditional

K972801 - ALLIANCE RUBBER, EC-GRIP

K972801 is an FDA 510(k) clearance for ALLIANCE RUBBER, 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 85-day FDA review.

K972801 · Alliance Rubber Products Sdn. Bhd. · General Hospital
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Oct 1997
Decision
85d
Days
Class 1
Risk

K972801 is an FDA 510(k) clearance for the ALLIANCE RUBBER, EC-GRIP. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Alliance Rubber Products Sdn. Bhd. (Pulau Pinang, MY). The FDA issued a Cleared decision on October 21, 1997 after a review of 85 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 Alliance Rubber Products Sdn. Bhd. devices

FDA 510(k) Submission Details - K972801

510(k) Number K972801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1997
Decision Date October 21, 1997
Days to Decision 85 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 faster than avg
Panel avg: 129d · This submission: 85d
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 441
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K972801.
Hi Coat Powder Free Latex Patient Examination Gloves
K972539 · P.T. Latexindo Tobaperkasa · Nov 1997
OMNI F.T. LATEX EXAMINATION GLOVE, POWDERED
K973134 · Omnigrace , Ltd. · Nov 1997
REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE
K971514 · London International Group, Inc. · Oct 1997
POWDER-FREE LATEX EXAMINATION GLOVE, TEAL OR WHITE (NON-COLORED)
K973811 · Absolute Quality Leadership, Inc. · Oct 1997
CONFORM NO POWDER (PROTEIN LABELING CLAIM) EXAMINATION GLOVES
K972785 · Ansell Perry · Sep 1997
AMBIDERM
K971102 · Supertex Industrial, S.A. DE C.V. · Aug 1997