Cleared Traditional

K840947 - CLOTH-HYPOALLERGENIC

K840947 is the FDA 510(k) clearance for CLOTH-HYPOALLERGENIC by Gainor Medical. It is a Class 1 General & Plastic Surgery device (product code KGX) cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K840947 · Gainor Medical · General & Plastic Surgery device
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Aug 1984
Decision
165d
Days
Class 1
Risk

K840947 is an FDA 510(k) clearance for the CLOTH-HYPOALLERGENIC. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Gainor Medical. The FDA issued a Cleared decision on August 17, 1984 after a review of 165 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - the FDA general and plastic surgery 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Gainor Medical devices

Submission Details

510(k) Number K840947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1984
Decision Date August 17, 1984
Days to Decision 165 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 115d · This submission: 165d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGX Tape And Bandage, Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
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 - KGX Tape And Bandage, Adhesive

All 71
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K840947.
LEUKOFLEX SURGICAL TAPE
K843876 · Beiersdorf, Inc. · Feb 1985
DISPOSABLE LATEX BANDAGE
K842301 · Inmed Corp. · Nov 1984
BAND-AID BRAND ADHESIVE BANDAGE-MEDICA
K842511 · Johnson & Johnson Professionals, Inc. · Nov 1984
MELOLITE
K833954 · Smith & Nephew, Inc. · Mar 1984
HYPAFIX DRESSING RETENTION SHEET
K833916 · Smith & Nephew, Inc. · Mar 1984
BREATHABLE OVERWRAY BANDAGE NON-ELAS
K833731 · American Medical Disposable, Inc. · Jan 1984