Cleared Traditional

K982694 - MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES

K982694 is an FDA 510(k) clearance for MEDLINE MEDCREST SURGICAL GOWNS AND SUR..., manufactured by Medline Industries, Inc.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K982694 · Medline Industries, Inc. · General Hospital
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Dec 1998
Decision
133d
Days
Class 2
Risk

K982694 is an FDA 510(k) clearance for the MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on December 14, 1998 after a review of 133 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 Medline Industries, Inc. devices

FDA 510(k) Submission Details - K982694

510(k) Number K982694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1998
Decision Date December 14, 1998
Days to Decision 133 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 129d · This submission: 133d
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 211
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K982694.
BARRIER SURGICAL GOWNS
K990395 · Johnson & Johnson Medical, Div. of Ethicon, Inc. · Apr 1999
STERILE BACK SURGICAL GOWN WITH HAND TOWEL
K984422 · Medical Sterilization, Inc. · Apr 1999
ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN
K982058 · Encompass Group, LLC · Jan 1999
ROTECNO 2000 SURGICAL GOWN
K982059 · Encompass Group, LLC · Nov 1998
MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS
K982693 · Medline Industries, Inc. · Oct 1998
MICROCOOL SURGICAL GOWN
K981393 · Kimberly-Clark Corp. · Jul 1998