Cleared Traditional

K880757 - TECNOL FLUID SHIELD SURGICAL MASK W/EYE...

K880757 is an FDA 510(k) clearance for TECNOL FLUID SHIELD SURGICAL MASK W/EYE..., 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 15-day FDA review.

K880757 · Tecnol New Jersey Wound Care, Inc. · General Hospital
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Mar 1988
Decision
15d
Days
Class 2
Risk

K880757 is an FDA 510(k) clearance for the TECNOL FLUID SHIELD SURGICAL MASK W/EYEGUARD. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Tecnol New Jersey Wound Care, Inc. (Fort Worth, US). The FDA issued a Cleared decision on March 11, 1988 after a review of 15 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 - K880757

510(k) Number K880757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1988
Decision Date March 11, 1988
Days to Decision 15 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
114d faster than avg
Panel avg: 129d · This submission: 15d
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 K880757.
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K874608 · Tecnol New Jersey Wound Care, Inc. · Dec 1987