Cleared Traditional

K893093 - FLOUROSHIELD RADIATION REDUCTION GLOVE (FDA 510(k) Clearance)

Class I General Hospital device.

K893093 · Acufex Microsurgical, Inc. · General Hospital
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Feb 1990
Decision
306d
Days
Class 1
Risk

K893093 is an FDA 510(k) clearance for the FLOUROSHIELD RADIATION REDUCTION GLOVE. Classified as Medical Glove, Specialty (product code LZC), Class I - General Controls.

Submitted by Acufex Microsurgical, Inc. (Norwood, US). The FDA issued a Cleared decision on February 13, 1990 after a review of 306 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Acufex Microsurgical, Inc. devices

Submission Details

510(k) Number K893093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1989
Decision Date February 13, 1990
Days to Decision 306 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
178d slower than avg
Panel avg: 128d · This submission: 306d
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.