Cleared Traditional

K102692 - SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO

K102692 is an FDA 510(k) clearance for SMS GOWNS (REINFORCED AND REINFORCED WI..., manufactured by Hangzhou Jincheng Medical Supplier Manufacture Co.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K102692 · Hangzhou Jincheng Medical Supplier Manufacture Co. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
172d
Days
Class 2
Risk

K102692 is an FDA 510(k) clearance for the SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, R.... Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Hangzhou Jincheng Medical Supplier Manufacture Co. (Pennington, US). The FDA issued a Cleared decision on March 11, 2011 after a review of 172 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.

FDA 510(k) Submission Details - K102692

510(k) Number K102692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2010
Decision Date March 11, 2011
Days to Decision 172 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 129d · This submission: 172d
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 270
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K102692.
JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE
K111067 · Kunshan Jiehong Nonwoven Product Co., Ltd. · 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
K101468 · 3M Company Corp · Apr 2011
FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK
K102971 · Microtek Medical, Inc. · Feb 2011
BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWN
K093835 · Bam Corp., Ltd. · Feb 2011
NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS
K102652 · Gri Medical & Electronic Technology Co., Ltd. · Feb 2011
K102692 · SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO
Download PDF FDA Summary Hangzhou Jincheng Med…