Cleared Traditional

K896076 - L(3)

K896076 is the FDA 510(k) clearance for L(3) by Advance Medical Designs, Inc.. It is a Class 1 General Hospital device (product code LZC) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K896076 · Advance Medical Designs, Inc. · General Hospital
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Jan 1990
Decision
77d
Days
Class 1
Risk

K896076 is an FDA 510(k) clearance for the L(3), LYSNIG LEAD LATEX RADIATION GLOVE(R). Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on January 4, 1990 after a review of 77 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 Advance Medical Designs, Inc. devices

Submission Details

510(k) Number K896076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1989
Decision Date January 04, 1990
Days to Decision 77 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
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZC Medical Glove, Specialty
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Disposable Medical Glove (examination Or Surgeon’s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc.
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 - LZC Medical Glove, Specialty

All 41
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K896076.
STERILE NITRILE POWDER-FREE EXAMINATION GLOVES
K010211 · Allegiance Healthcare Corp. · Feb 2001
FLUORO-SHIELD RADIATION REDUCTION GLOVES
K920620 · Acufex Microsurgical, Inc. · Jun 1993
FLOUROSHIELD RADIATION REDUCTION GLOVE
K893093 · Acufex Microsurgical, Inc. · Feb 1990
ESP RADIATION REDUCTION EXAMINATION GLOVES
K891968 · Boston Scientific Corp · May 1989