Cleared Traditional

K843475 - PHARMA-PLAST SINGLE USE OVERSHOES

K843475 is the FDA 510(k) clearance for PHARMA-PLAST SINGLE USE OVERSHOES by Zimmar Consulting , Ltd.. It is a Class 1 General Hospital device (product code FXP) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K843475 · Zimmar Consulting , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1984
Decision
55d
Days
Class 1
Risk

K843475 is an FDA 510(k) clearance for the PHARMA-PLAST SINGLE USE OVERSHOES. Classified as Cover, Shoe, Operating-room (product code FXP), Class I - General Controls.

Submitted by Zimmar Consulting , Ltd. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1984 after a review of 55 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 Zimmar Consulting , Ltd. devices

Submission Details

510(k) Number K843475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1984
Decision Date October 31, 1984
Days to Decision 55 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
74d faster than avg
Panel avg: 129d · This submission: 55d
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.

Regulatory Peers - FXP Cover, Shoe, Operating-room

All 8
Devices cleared under the same product code (FXP) and FDA review panel - the closest regulatory comparables to K843475.
NON-SKID SHOE COVERS
K872797 · Abco Dealers, Inc. · Aug 1987
NONCONDUCTIVE SHOE COVER
K864026 · Kimberly-Clark Corp. · Oct 1986
DISPOSABLE SHOE COVERS AND NURSES CAPS
K862726 · Abco Dealers, Inc. · Aug 1986
MICRO-MITT
K830821 · CooperVision, Inc. · Apr 1983
NON-CONDUCTIVE SHOE COVERS
K801616 · Procter & Gamble Mfg. Co. · Aug 1980
CONDUCTIVE SHOE COVERS
K801617 · Procter & Gamble Mfg. Co. · Aug 1980