Cleared Traditional

K042111 - PROMEDICAL SURGICAL GOWNS

K042111 is an FDA 510(k) clearance for PROMEDICAL SURGICAL GOWNS, manufactured by Promedical Products Co., Ltd.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K042111 · Promedical Products Co., Ltd. · General Hospital
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Dec 2004
Decision
127d
Days
Class 2
Risk

K042111 is an FDA 510(k) clearance for the PROMEDICAL SURGICAL GOWNS. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Promedical Products Co., Ltd. (Starkville, US). The FDA issued a Cleared decision on December 10, 2004 after a review of 127 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 Promedical Products Co., Ltd. devices

FDA 510(k) Submission Details - K042111

510(k) Number K042111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2004
Decision Date December 10, 2004
Days to Decision 127 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
2d faster than avg
Panel avg: 129d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYA Device Classification - Class 2, Special Controls

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 182
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K042111.
COMPEL MLR SURGICAL GOWNS
K041541 · Standard Textile Co., Inc. · Mar 2005
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