Cleared Traditional

K840229 - CONTROL COVER GOWN

K840229 is an FDA 510(k) clearance for CONTROL COVER GOWN, manufactured by Kimberly-Clark Corp.. The device is a Class 2 General Hospital device with product code FYC cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K840229 · Kimberly-Clark Corp. · General Hospital
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Mar 1984
Decision
59d
Days
Class 2
Risk

K840229 is an FDA 510(k) clearance for the CONTROL COVER GOWN. Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by Kimberly-Clark Corp. (Mchenry, US). The FDA issued a Cleared decision on March 19, 1984 after a review of 59 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 Kimberly-Clark Corp. devices

FDA 510(k) Submission Details - K840229

510(k) Number K840229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1984
Decision Date March 19, 1984
Days to Decision 59 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 129d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYC Device Classification - Class 2, Special Controls

Product Code FYC Gown, Isolation, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FYC Gown, Isolation, Surgical

All 33
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K840229.
CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS
K982369 · Allegiance Healthcare Corp. · Aug 1998
BUSE STAFF PROTECTION GOWNS AND KITS
K941845 · Busse Hospital Disposables, Inc. · May 1995
ISOLATION GOWN
K874888 · Sage Products, Inc. · Dec 1987
BARRIER PLUS SURGEON GOWNS
K801162 · American Hospital Supply Corp. · May 1980
ISOLATION GOWN
K780605 · Abco Dealers, Inc. · May 1978
ISOLATION GOWN PACK
K761080 · American Hospital Supply Corp. · Jan 1977