Cleared Traditional

K982693 - MEDINE DISPOSABLE STERILE ZONED IMPERVI...

K982693 is the FDA 510(k) clearance for MEDINE DISPOSABLE STERILE ZONED IMPERVI... by Medline Industries, Inc.. It is a Class 2 General Hospital device (product code FYA) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K982693 · Medline Industries, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
86d
Days
Class 2
Risk

K982693 is an FDA 510(k) clearance for the MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS. 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 October 28, 1998 after a review of 86 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K982693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1998
Decision Date October 28, 1998
Days to Decision 86 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 129d · This submission: 86d
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 K982693.
CONVERTORS BREATHABLE SURGICAL GOWNS
K992514 · Allegiance Healthcare Corp. · Aug 1999
CONVERTORS SURGICAL GOWNS
K991034 · Allegiance Healthcare Corp. · Apr 1999
MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES
K982694 · Medline Industries, Inc. · Dec 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
PROVISION SURGICAL HELMET SYSTEM
K972832 · Depuy, Inc. · Oct 1997