Cleared Traditional

K943809 - MONOGARD FACE SHIELD

K943809 is an FDA 510(k) clearance for MONOGARD FACE SHIELD, manufactured by White Knight Healthcare. The device is a Class 1 General Hospital device with product code LYU cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K943809 · White Knight Healthcare · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
116d
Days
Class 1
Risk

K943809 is an FDA 510(k) clearance for the MONOGARD FACE SHIELD. Classified as Accessory, Surgical Apparel (product code LYU), Class I - General Controls.

Submitted by White Knight Healthcare (Ashville, US). The FDA issued a Cleared decision on November 28, 1994 after a review of 116 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 White Knight Healthcare devices

FDA 510(k) Submission Details - K943809

510(k) Number K943809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1994
Decision Date November 28, 1994
Days to Decision 116 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 129d · This submission: 116d
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 10
Devices cleared under the same product code (LYU) and FDA review panel - the closest regulatory comparables to K943809.
DISPOSABLE APRON
K964364 · Instrument Makar, Inc. · Feb 1997
DEPUY DISPOSABLE FILTER/HOOD
K961791 · Depuy, Inc. · Aug 1996
MAKAR FULL AND HALF FACE SHIELD
K942828 · Instrument Makar, Inc. · Feb 1995
FACE-IT SHIELD
K942022 · Onyx Medical Corp. · Jul 1994
PROCEL(TM) DERMALINER GLOVE
K931094 · W.L. Gore & Associates, Inc. · Feb 1994
ULTRATUFF CUT RESISTANT GLOVE LINER
K925628 · Baxter Healthcare Corp · Jul 1993