Cleared Traditional

K894064 - STERILE HAND COVER (FDA 510(k) Clearance)

Class I General Hospital device.

K894064 · Sage Products, Inc. · General Hospital
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Aug 1989
Decision
64d
Days
Class 1
Risk

K894064 is an FDA 510(k) clearance for the STERILE HAND COVER. Classified as Accessory, Surgical Apparel (product code LYU), Class I - General Controls.

Submitted by Sage Products, Inc. (Cary, US). The FDA issued a Cleared decision on August 11, 1989 after a review of 64 days - a notably fast clearance cycle.

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: 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 Sage Products, Inc. devices

Submission Details

510(k) Number K894064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1989
Decision Date August 11, 1989
Days to Decision 64 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
64d faster than avg
Panel avg: 128d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYU Accessory, Surgical Apparel
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.