Cleared Traditional

GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) (K971920) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K971920 · Customed, Inc. · General Hospital
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Dec 1997
Decision
195d
Days
Class 2
Risk

K971920 is an FDA 510(k) clearance for the GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522). Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Customed, Inc. (Fajardo, US). The FDA issued a Cleared decision on December 4, 1997 after a review of 195 days - an extended review 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: 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 Customed, Inc. devices

Submission Details

510(k) Number K971920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1997
Decision Date December 04, 1997
Days to Decision 195 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 129d · This submission: 195d
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 118
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K971920.
MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES
K982694 · Medline Industries, Inc. · Dec 1998
MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS
K982693 · Medline Industries, Inc. · Oct 1998
MICROCOOL SURGICAL GOWN
K981393 · Kimberly-Clark Corp. · Jul 1998
PROVISION SURGICAL HELMET SYSTEM
K972832 · Depuy, Inc. · Oct 1997
CONVERTORS POLYOLEFIN FABRIC GOWNS
K961341 · Baxter Healthcare Corp · Oct 1996
DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL
K961239 · Depuy, Inc. · Sep 1996