Cleared Traditional

K931288 - ISOLAIR 2 FULL FACE SPLASH GUARD

K931288 is an FDA 510(k) clearance for ISOLAIR 2 FULL FACE SPLASH GUARD, manufactured by Louis M. Gerson Co., Inc.. The device is a Class 1 General Hospital device with product code LYU cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K931288 · Louis M. Gerson Co., Inc. · General Hospital
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Jan 1994
Decision
315d
Days
Class 1
Risk

K931288 is an FDA 510(k) clearance for the ISOLAIR 2 FULL FACE SPLASH GUARD. Classified as Accessory, Surgical Apparel (product code LYU), Class I - General Controls.

Submitted by Louis M. Gerson Co., Inc. (Middleboro, US). The FDA issued a Cleared decision on January 21, 1994 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Louis M. Gerson Co., Inc. devices

FDA 510(k) Submission Details - K931288

510(k) Number K931288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1993
Decision Date January 21, 1994
Days to Decision 315 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
186d slower than avg
Panel avg: 129d · This submission: 315d
Pathway characteristics
Predicate-based equivalence.

LYU Device Classification - Class 1, General Controls

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.

Regulatory Peers - LYU Accessory, Surgical Apparel

All 16
Devices cleared under the same product code (LYU) and FDA review panel - the closest regulatory comparables to K931288.
FACE-IT SHIELD
K942022 · Onyx Medical Corp. · Jul 1994
TECNOL SPLASHGUARD
K934842 · Tecnol Medical Products, Inc. · Mar 1994
PROCEL(TM) DERMALINER GLOVE
K931094 · W.L. Gore & Associates, Inc. · Feb 1994
ULTRATUFF CUT RESISTANT GLOVE LINER
K925628 · Baxter Healthcare Corp · Jul 1993
GUARDALL SHIELD
K915415 · Anago, Inc. · Oct 1992
CUT RESISTANT GLOVE LINER
K902633 · Biomet, Inc. · Jul 1990