Cleared Traditional

K833758 - P.T.I. DRESSING CHANGE TRAYS

K833758 is an FDA 510(k) clearance for P.T.I. DRESSING CHANGE TRAYS, manufactured by Packaging Technologies, Inc.. The device is a Class 1 General Hospital device with product code FMC cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K833758 · Packaging Technologies, Inc. · General Hospital
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Jan 1984
Decision
92d
Days
Class 1
Risk

K833758 is an FDA 510(k) clearance for the P.T.I. DRESSING CHANGE TRAYS. Classified as Patient Examination Glove (product code FMC), Class I - General Controls.

Submitted by Packaging Technologies, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1984 after a review of 92 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 Packaging Technologies, Inc. devices

FDA 510(k) Submission Details - K833758

510(k) Number K833758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1983
Decision Date January 26, 1984
Days to Decision 92 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
37d faster than avg
Panel avg: 129d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

FMC Device Classification - Class 1, General Controls

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 16
Devices cleared under the same product code (FMC) and FDA review panel - the closest regulatory comparables to K833758.
SURGICAL INSTRUMENT KIT, DISPOSABLE
K923175 · Ulti-Med Intl., Inc. · Jun 1993
COMFIT, PATIENT EXAMINATION GLOVES
K903746 · Wembley Rubber Products (M) Sdn Bhd · Sep 1990
ROCKET SEX CRIME KIT
K883805 · A & A Medical, Inc. · Jan 1989
ORTHOPEDIC SURGICAL GLOVE
K831564 · Ansell, Inc. · Jul 1983
FINGER COTS
K821028 · Abco Dealers, Inc. · Apr 1982
SUTURE WOUND TRAY MILFORD WHITTINSVILLE
K802386 · American Medical Disposable, Inc. · Nov 1980