Cleared Traditional

K880383 - KIMBERLY-CLARK FULL LENGTH HEAVY DUTY APRON

K880383 is an FDA 510(k) clearance for KIMBERLY-CLARK FULL LENGTH HEAVY DUTY APRON, manufactured by Kimberly-Clark Corp.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K880383 · Kimberly-Clark Corp. · General Hospital
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Jun 1988
Decision
147d
Days
Class 2
Risk

K880383 is an FDA 510(k) clearance for the KIMBERLY-CLARK FULL LENGTH HEAVY DUTY APRON. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Kimberly-Clark Corp. (Roswell, US). The FDA issued a Cleared decision on June 23, 1988 after a review of 147 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Kimberly-Clark Corp. devices

FDA 510(k) Submission Details - K880383

510(k) Number K880383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1988
Decision Date June 23, 1988
Days to Decision 147 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
18d slower than avg
Panel avg: 129d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYA Device Classification - Class 2, Special Controls

Product Code FYA Gown, 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 - FYA Gown, Surgical

All 159
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K880383.
STERILE VIEW DISP. HOOD/GOWN UV, BARRIER HOOD, UV
K901536 · Depuy, Inc. · Nov 1990
CONVERTORS BREATHABLE GOWN MATERIAL PRODUCT LINE
K896935 · Baxter Healthcare Corp · Feb 1990
KIMBERLY-CLARK IMPERVIOUS OPEN BACK GOWN
K880382 · Kimberly-Clark Corp. · Jun 1988
KIMBERLY-CLARK PROTECTIVE SLEEVE
K880386 · Kimberly-Clark Corp. · Jun 1988
THEATRE GOWNS
K872758 · Smith & Nephew, Inc. · Jul 1987
SPUNGUARD PLUS SURGICAL GOWN
K861600 · Kimberly-Clark Corp. · May 1986