Cleared Traditional

K111067 - JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE

K111067 is an FDA 510(k) clearance for JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, manufactured by Kunshan Jiehong Nonwoven Product Co., Ltd.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K111067 · Kunshan Jiehong Nonwoven Product Co., Ltd. · General Hospital
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Aug 2011
Decision
106d
Days
Class 2
Risk

K111067 is an FDA 510(k) clearance for the JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - .... Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Kunshan Jiehong Nonwoven Product Co., Ltd. (San Diego, US). The FDA issued a Cleared decision on August 2, 2011 after a review of 106 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.

FDA 510(k) Submission Details - K111067

510(k) Number K111067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2011
Decision Date August 02, 2011
Days to Decision 106 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 129d · This submission: 106d
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 266
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K111067.
DISPOSABLE SURGICAL GOWNS
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K111535 · Exact Medical Manufacturing, Inc. · Aug 2011
SURGICAL PROCEDURE PACKS
K110724 · Omnia Spa · Jun 2011
3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE
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SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO
K102692 · Hangzhou Jincheng Medical Supplier Manufacture Co. · Mar 2011
K111067 · JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE
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