Cleared Traditional

K962096 - MEDLINE

K962096 is the FDA 510(k) clearance for MEDLINE by Medline Industries, Inc.. It is a Class 1 General Hospital device (product code LYY) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K962096 · Medline Industries, Inc. · General Hospital
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Nov 1996
Decision
175d
Days
Class 1
Risk

K962096 is an FDA 510(k) clearance for the MEDLINE, HYPOALLERGENIC, PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATI.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on November 19, 1996 after a review of 175 days - an extended review 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: 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.

View all Medline Industries, Inc. devices

Submission Details

510(k) Number K962096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1996
Decision Date November 19, 1996
Days to Decision 175 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
46d slower than avg
Panel avg: 129d · This submission: 175d
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 149
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K962096.
LOW POWDER POLYMER LATEX EXAMINATION GLOVES (WITH PROTEIN LABELING CLAIM)
K973871 · Hartalega Sdn Bhd · Dec 1997
ALLEGIANCE NON STERILE POWDER FREE LOW PROTEIN LATEX EXAMIATION GLOVES
K972291 · Allegiance Healthcare Corp. · Jul 1997
LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)
K970794 · Siam Sempermed Corp., Ltd. · May 1997
COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED)
K953213 · Wembley Rubber Products (M) Sdn Bhd · Oct 1996
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES
K954416 · Hartalega Sdn Bhd · Oct 1996
LATEX PATIENT EXAMINATION GLOVE (BLUE) (MODIFICATION)
K961415 · Siam Sempermed Corp., Ltd. · Oct 1996