Cleared Traditional

K842301 - DISPOSABLE LATEX BANDAGE

K842301 is an FDA 510(k) clearance for DISPOSABLE LATEX BANDAGE, manufactured by Inmed Corp.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K842301 · Inmed Corp. · General & Plastic Surgery device
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Nov 1984
Decision
147d
Days
Class 1
Risk

K842301 is an FDA 510(k) clearance for the DISPOSABLE LATEX BANDAGE. Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Inmed Corp. (Norcross, US). The FDA issued a Cleared decision on November 5, 1984 after a review of 147 days - within the typical 510(k) review window.

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 Inmed Corp. devices

FDA 510(k) Submission Details - K842301

510(k) Number K842301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1984
Decision Date November 05, 1984
Days to Decision 147 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 115d · This submission: 147d
Pathway characteristics
Predicate-based equivalence.

KGX Device Classification - Class 1, General Controls

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 89
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K842301.
LEUKOPOR SURGICAL TAPE
K843874 · Beiersdorf, Inc. · Feb 1985
LEUKOSILK
K843875 · Beiersdorf, Inc. · Feb 1985
LEUKOFLEX SURGICAL TAPE
K843876 · Beiersdorf, Inc. · Feb 1985
BAND-AID BRAND ADHESIVE BANDAGE-MEDICA
K842511 · Johnson & Johnson Professionals, Inc. · Nov 1984
MEDICAL TAPE
K840446 · Lectec Corp. · Oct 1984
MEDICAL ADHESIVE FOAM TAPE
K840448 · Lectec Corp. · Oct 1984