Cleared Traditional

SUTURE WOUND TRAY MILFORD WHITTINSVILLE (K802386) - FDA 510(k) Clearance

Class I General Hospital device.

K802386 · American Medical Disposable, Inc. · General Hospital
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Nov 1980
Decision
41d
Days
Class 1
Risk

K802386 is an FDA 510(k) clearance for the SUTURE WOUND TRAY MILFORD WHITTINSVILLE. Classified as Patient Examination Glove (product code FMC), Class I - General Controls.

Submitted by American Medical Disposable, Inc. (Walker, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 41 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Medical Disposable, Inc. devices

Submission Details

510(k) Number K802386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1980
Decision Date November 12, 1980
Days to Decision 41 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
88d faster than avg
Panel avg: 129d · This submission: 41d
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.