Cleared Traditional

K982694 - MEDLINE MEDCREST SURGICAL GOWNS AND SUR...

K982694 is the FDA 510(k) clearance for MEDLINE MEDCREST SURGICAL GOWNS AND SUR... by Medline Industries, Inc.. It is a Class 2 General Hospital device (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

Submission Details

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.

Device Classification

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 147
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K982694.
CONVERTORS SURGICAL GOWNS
K992951 · Allegiance Healthcare Corp. · Sep 1999
CONVERTORS BREATHABLE SURGICAL GOWNS
K992514 · Allegiance Healthcare Corp. · Aug 1999
CONVERTORS SURGICAL GOWNS
K991034 · Allegiance Healthcare Corp. · Apr 1999
MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS
K982693 · Medline Industries, Inc. · Oct 1998
MICROCOOL SURGICAL GOWN
K981393 · Kimberly-Clark Corp. · Jul 1998
GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)
K971920 · Customed, Inc. · Dec 1997