Cleared Traditional

K972291 - ALLEGIANCE NON STERILE POWDER FREE LOW PROTEIN LATEX EXAMIATION GLOVES

K972291 is an FDA 510(k) clearance for ALLEGIANCE NON STERILE POWDER FREE LOW ..., manufactured by Allegiance Healthcare Corp.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K972291 · Allegiance Healthcare Corp. · General Hospital
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Jul 1997
Decision
39d
Days
Class 1
Risk

K972291 is an FDA 510(k) clearance for the ALLEGIANCE NON STERILE POWDER FREE LOW PROTEIN LATEX EXAMIATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Allegiance Healthcare Corp. (Mcgraw Park, US). The FDA issued a Cleared decision on July 28, 1997 after a review of 39 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 Allegiance Healthcare Corp. devices

FDA 510(k) Submission Details - K972291

510(k) Number K972291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1997
Decision Date July 28, 1997
Days to Decision 39 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 129d · This submission: 39d
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 782
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K972291.
PATIENT LATEX EXAMINATION GLOVE (PREPOWDERED)
K971629 · Besglove Medicare Sdn. Bhd. · Aug 1997
UNIGLOVES
K971731 · Uni-Glove (Usa), Inc. · Aug 1997
POWDER-FREE PATIENT EXAMINATION GLOVES
K971949 · Tekmedic (M) Sdn Bhd · Jul 1997
LATEX EXAMINATION GLOVES
K970770 · Oon Corp. Resources · Jul 1997
UNIJECT EXAMINATION GLOVES
K970191 · Uniject Gloves , Ltd. · Jul 1997
LATEX EXAMINATION GLOVES, POWDER FREE
K970977 · Arista Medi Prima · Jun 1997