Cleared Traditional

P.T.I. DRESSING CHANGE TRAYS (K833758) - FDA 510(k) Clearance

Class I General Hospital device.

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

Submission Details

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.

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.