Cleared Traditional

K840620 - TPN/CVP DRESSING CHANGE KIT

K840620 is the FDA 510(k) clearance for TPN/CVP DRESSING CHANGE KIT by Marwood Medical, Inc.. It is a Class 1 General Hospital device (product code FMC) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K840620 · Marwood Medical, Inc. · General Hospital
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May 1984
Decision
106d
Days
Class 1
Risk

K840620 is an FDA 510(k) clearance for the TPN/CVP DRESSING CHANGE KIT. Classified as Patient Examination Glove (product code FMC), Class I - General Controls.

Submitted by Marwood Medical, Inc. (Walker, US). The FDA issued a Cleared decision on May 30, 1984 after a review of 106 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Marwood Medical, Inc. devices

Submission Details

510(k) Number K840620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1984
Decision Date May 30, 1984
Days to Decision 106 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 129d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FMC Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
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 - FMC Patient Examination Glove

All 8
Devices cleared under the same product code (FMC) and FDA review panel - the closest regulatory comparables to K840620.
COMFIT, PATIENT EXAMINATION GLOVES
K903746 · Wembley Rubber Products (M) Sdn Bhd · Sep 1990
FINGER COTS
K821028 · Abco Dealers, Inc. · Apr 1982
SUTURE WOUND TRAY MILFORD WHITTINSVILLE
K802386 · American Medical Disposable, Inc. · Nov 1980
EMBOSSED DISP. POLY. GLOVES #5101-03
K801997 · Pollak (Intl.), Ltd. · Sep 1980
STERILE EXAMINATION GLOVE #5121-5126
K801998 · Pollak (Intl.), Ltd. · Sep 1980
CONPHAR EXAM. GLOVES, POLYETHYLENE
K791805 · Conphar, Inc. · Oct 1979