Cleared Traditional

AGAFAR FACE SHIELD (K935779) - FDA 510(k) Clearance

Class I General Hospital device.

K935779 · Infection Control Products, Inc. · General Hospital
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Feb 1994
Decision
60d
Days
Class 1
Risk

K935779 is an FDA 510(k) clearance for the AGAFAR FACE SHIELD. Classified as Accessory, Surgical Apparel (product code LYU), Class I - General Controls.

Submitted by Infection Control Products, Inc. (Gardendale, US). The FDA issued a Cleared decision on February 1, 1994 after a review of 60 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - 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 Infection Control Products, Inc. devices

Submission Details

510(k) Number K935779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1993
Decision Date February 01, 1994
Days to Decision 60 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
69d faster than avg
Panel avg: 129d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYU Accessory, Surgical Apparel
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4040
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.