Cleared Traditional

FAR-EAST SHOE COVERS (K971191) - FDA 510(k) Clearance

Class I General Hospital device.

K971191 · Far East Science & Technology Development Co., Ltd. · General Hospital
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Jul 1997
Decision
101d
Days
Class 1
Risk

K971191 is an FDA 510(k) clearance for the FAR-EAST SHOE COVERS. Classified as Cover, Shoe, Operating-room (product code FXP), Class I - General Controls.

Submitted by Far East Science & Technology Development Co., Ltd. (Garden Grove, US). The FDA issued a Cleared decision on July 10, 1997 after a review of 101 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - 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 Far East Science & Technology Development Co., Ltd. devices

Submission Details

510(k) Number K971191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1997
Decision Date July 10, 1997
Days to Decision 101 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 129d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FXP Cover, Shoe, Operating-room
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4040
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.