Cleared Traditional

K934974 - FLUID RESISTANT MASK WITH WRAP AROUND EYE SHIELD

K934974 is an FDA 510(k) clearance for FLUID RESISTANT MASK WITH WRAP AROUND E..., manufactured by Mid America Medical, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K934974 · Mid America Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
176d
Days
Class 2
Risk

K934974 is an FDA 510(k) clearance for the FLUID RESISTANT MASK WITH WRAP AROUND EYE SHIELD. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Mid America Medical, Inc. (Covington, US). The FDA issued a Cleared decision on April 13, 1994 after a review of 176 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 Mid America Medical, Inc. devices

FDA 510(k) Submission Details - K934974

510(k) Number K934974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1993
Decision Date April 13, 1994
Days to Decision 176 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
47d slower than avg
Panel avg: 129d · This submission: 176d
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 K934974.
3M SURGICAL MASK WITH FACE SHEILD
K940707 · 3M Company · May 1994
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