Cleared Traditional

K891212 - APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE

K891212 is an FDA 510(k) clearance for APRONS, manufactured by Pro-Safe Professional Linens, Inc.. The device is a Class 1 General Hospital device with product code FXO cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K891212 · Pro-Safe Professional Linens, Inc. · General Hospital
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Apr 1989
Decision
38d
Days
Class 1
Risk

K891212 is an FDA 510(k) clearance for the APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE. Classified as Suit, Surgical (product code FXO), Class I - General Controls.

Submitted by Pro-Safe Professional Linens, Inc. (Grand Junction, US). The FDA issued a Cleared decision on April 14, 1989 after a review of 38 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 Pro-Safe Professional Linens, Inc. devices

FDA 510(k) Submission Details - K891212

510(k) Number K891212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1989
Decision Date April 14, 1989
Days to Decision 38 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
91d faster than avg
Panel avg: 129d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

FXO Device Classification - Class 1, General Controls

Product Code FXO Suit, Surgical
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.