Cleared Traditional

O.R./SURGEONS GOWN, ITEM NO. 4942 (K921157) - FDA 510(k) Clearance

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

K921157 · The Sewing Source, Inc. · General Hospital
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Jul 1993
Decision
492d
Days
Class 2
Risk

K921157 is an FDA 510(k) clearance for the O.R./SURGEONS GOWN, ITEM NO. 4942. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by The Sewing Source, Inc. (Spring Hope, US). The FDA issued a Cleared decision on July 9, 1993 after a review of 492 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all The Sewing Source, Inc. devices

Submission Details

510(k) Number K921157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1992
Decision Date July 09, 1993
Days to Decision 492 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
363d slower than avg
Panel avg: 129d · This submission: 492d
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 104
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K921157.
DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL
K961239 · Depuy, Inc. · Sep 1996
INTERWOVEN(TM) REUSABLE SURGICAL GOWN
K945658 · Baxter Healthcare Corp · Mar 1995
INTERWOVEN OPTIGUARD REUSABLE GOWN MATERIAL
K944138 · Baxter Healthcare Corp · Dec 1994
RS OPTIGUARD GOWN & DRAPE MATERIAL
K925715 · Baxter Healthcare Corp · May 1993
STERILE CONVERTOR SAFECARE GOWN AND DRAPE
K920837 · Baxter Healthcare Corp · May 1992
STERILE VIEW DISP. HOOD/GOWN UV, BARRIER HOOD, UV
K901536 · Depuy, Inc. · Nov 1990