Cleared Traditional

K033057 - DEROYAL SURGICAL GOWNS

K033057 is the FDA 510(k) clearance for DEROYAL SURGICAL GOWNS by Deroyal. It is a Class 2 General Hospital device (product code FYA) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K033057 · Deroyal · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
52d
Days
Class 2
Risk

K033057 is an FDA 510(k) clearance for the DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Deroyal (Powell, US). The FDA issued a Cleared decision on November 20, 2003 after a review of 52 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 Deroyal devices

Submission Details

510(k) Number K033057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date November 20, 2003
Days to Decision 52 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 129d · This submission: 52d
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 148
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K033057.
PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS
K043017 · Medline Industries, Inc. · Mar 2005
MEDLINE SURGICAL GOWNS
K043585 · Medline Industries, Inc. · Mar 2005
STRYKER T4 HYTREL ZIPPER TOGA
K040764 · Stryker Corp. · Apr 2004
MEDLINE REUSABLE SURGICAL GOWNS (100X)
K031933 · Medline Industries, Inc. · Sep 2003
DEROYAL GOWNS, STERILE, NON-STERILE
K030364 · Deroyal Industries, Inc. · Apr 2003
DHS DISPOSABLE HOOD SYSTEM
K021992 · Biomet, Inc. · Jan 2003