Cleared Traditional

K934969 - DUALGARD FACE SHIELD

K934969 is an FDA 510(k) clearance for DUALGARD FACE SHIELD, manufactured by White Knight Healthcare. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K934969 · White Knight Healthcare · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
165d
Days
Class 2
Risk

K934969 is an FDA 510(k) clearance for the DUALGARD FACE SHIELD. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by White Knight Healthcare (Childersburg, US). The FDA issued a Cleared decision on March 28, 1994 after a review of 165 days - an extended review 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: 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 - K934969

510(k) Number K934969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1993
Decision Date March 28, 1994
Days to Decision 165 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
36d slower than avg
Panel avg: 129d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FXX Device Classification - Class 2, Special Controls

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FXX Mask, Surgical

All 516
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K934969.
TECNOL PCM 2000
K932834 · Tecnol Medical Products, Inc. · May 1994
FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR
K932137 · Tecnol Medical Products, Inc. · Apr 1994
BARRIER LASER PLUS FACE MASK
K934194 · Johnson & Johnson Medical, Inc. · Mar 1994
BARRIER EXTRA PROTECTION PLUS FACE MASK
K920108 · Johnson & Johnson Medical, Inc. · Feb 1994
BUFFALO FILTER SURGICAL MASK
K930067 · Buffalo Filter Co., Inc. · Nov 1993
TECNOL FLUIDSHIELD INFECTION CONTROL MASK
K915817 · Tecnol Medical Products, Inc. · Jan 1993