Cleared Traditional

PATIENT EXAMINATION GLOVES (LATEX) (K892791) - FDA 510(k) Clearance

Class I Physical Medicine device.

K892791 · Union Industrial Co., Ltd. · Physical Medicine device
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Aug 1989
Decision
135d
Days
Class 1
Risk

K892791 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVES (LATEX). Classified as Footrest, Wheelchair (product code IMM), Class I - General Controls.

Submitted by Union Industrial Co., Ltd. (Bangkrut Pha Smutpar, TH). The FDA issued a Cleared decision on August 24, 1989 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3920 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Union Industrial Co., Ltd. devices

Submission Details

510(k) Number K892791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1989
Decision Date August 24, 1989
Days to Decision 135 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 115d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IMM Footrest, Wheelchair
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3920
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.