Cleared Traditional

K832194 - SURGICAL FACE MASK-DISPOSABLE

K832194 is an FDA 510(k) clearance for SURGICAL FACE MASK-DISPOSABLE, manufactured by Tecnol New Jersey Wound Care, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K832194 · Tecnol New Jersey Wound Care, Inc. · General Hospital
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Jul 1983
Decision
18d
Days
Class 2
Risk

K832194 is an FDA 510(k) clearance for the SURGICAL FACE MASK-DISPOSABLE. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Tecnol New Jersey Wound Care, Inc. (Hammonton, US). The FDA issued a Cleared decision on July 26, 1983 after a review of 18 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 Tecnol New Jersey Wound Care, Inc. devices

FDA 510(k) Submission Details - K832194

510(k) Number K832194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1983
Decision Date July 26, 1983
Days to Decision 18 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 129d · This submission: 18d
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 444
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K832194.
PERITONEAL DIALYSIS COIL CATHETER
K850247 · Sil-Med Corp. · Feb 1985
HIGH FILTRATION ISO-MASK
K831148 · Tecnol New Jersey Wound Care, Inc. · Jul 1984
TWO-PLY PAPER FACE FACE MASK
K832281 · Abco Dealers, Inc. · Aug 1983
SURGICAL FACE MASK
K830890 · Busse Hospital Disposables, Inc. · Apr 1983
SPUNGUARD FACE MASK
K823078 · Kimberly-Clark Corp. · Jan 1983
DISPOSABLE SURGICAL FACE MASK
K820893 · Anago, Inc. · Apr 1982