Cleared Traditional

K920620 - FLUORO-SHIELD RADIATION REDUCTION GLOVES

K920620 is the FDA 510(k) clearance for FLUORO-SHIELD RADIATION REDUCTION GLOVES by Acufex Microsurgical, Inc.. It is a Class 1 General Hospital device (product code LZC) cleared through the Traditional 510(k) pathway after a 497-day FDA review.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
368d slower than avg
Panel avg: 129d · 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.

Regulatory Peers - LZC Medical Glove, Specialty

All 40
Devices cleared under the same product code (LZC) and FDA review panel - the closest regulatory comparables to K920620.
POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM
K083305 · Wrp Asia Pacific Sdn. Bhd. · Jun 2009
KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM
K081089 · Kimberly-Clark Corp. · Jul 2008
STERILE NITRILE POWDER-FREE EXAMINATION GLOVES
K010211 · Allegiance Healthcare Corp. · Feb 2001
FLOUROSHIELD RADIATION REDUCTION GLOVE
K893093 · Acufex Microsurgical, Inc. · Feb 1990
ESP RADIATION REDUCTION EXAMINATION GLOVES
K891968 · Boston Scientific Corp · May 1989