Cleared Traditional

K920620 - FLUORO-SHIELD RADIATION REDUCTION GLOVES (FDA 510(k) Clearance)

Class I General Hospital device.

K920620 · Acufex Microsurgical, Inc. · General Hospital
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Jun 1993
Decision
497d
Days
Class 1
Risk

K920620 is an FDA 510(k) clearance for the FLUORO-SHIELD RADIATION REDUCTION GLOVES. Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Acufex Microsurgical, Inc. (Great Neck, US). The FDA issued a Cleared decision on June 22, 1993 after a review of 497 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Acufex Microsurgical, Inc. devices

Submission Details

510(k) Number K920620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1992
Decision Date June 22, 1993
Days to Decision 497 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
369d slower than avg
Panel avg: 128d · This submission: 497d
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.