Cleared Traditional

K974304 - GERMICIDAL CLOTH

K974304 is an FDA 510(k) clearance for GERMICIDAL CLOTH, manufactured by Convatec, A Division of E.R. Squibb & Sons. The device is a Class 1 General Hospital device with product code LRJ cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K974304 · Convatec, A Division of E.R. Squibb & Sons · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
57d
Days
Class 1
Risk

K974304 is an FDA 510(k) clearance for the GERMICIDAL CLOTH. Classified as Disinfectant, Medical Devices (product code LRJ), Class I - General Controls.

Submitted by Convatec, A Division of E.R. Squibb & Sons (St. Louis, US). The FDA issued a Cleared decision on January 13, 1998 after a review of 57 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6890 - 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 Convatec, A Division of E.R. Squibb & Sons devices

FDA 510(k) Submission Details - K974304

510(k) Number K974304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1997
Decision Date January 13, 1998
Days to Decision 57 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 129d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

LRJ Device Classification - Class 1, General Controls

Product Code LRJ Disinfectant, Medical Devices
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6890
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 - LRJ Disinfectant, Medical Devices

All 37
Devices cleared under the same product code (LRJ) and FDA review panel - the closest regulatory comparables to K974304.
CITREX HOSPITAL SPRAY DISINFECTANT
K982985 · Caltech Industries, Inc. · Nov 1998
KLEENASEPTIC
K981023 · Metrex Research Corp. · Apr 1998
T.B.Q. RTU
K980369 · STERIS Corporation · Feb 1998
NOVIGUARD QUICK DRY
K961044 · Dr. Novis Smith & Co., Inc. · Jul 1997
BLUE CHIP GERMICIDAL CLEANER & DEODORANT
K970825 · S.C. Johnson Professional · Mar 1997
CIDE-SWIPES P-100B & CIDE-SWIPES C-100A
K964376 · Mp Scientific, Inc. · Dec 1996