Cleared Traditional

K062479 - JOYKEY SURGICAL GOWNS (STERILE)

K062479 is an FDA 510(k) clearance for JOYKEY SURGICAL GOWNS (STERILE), manufactured by Joykey Industryial , Ltd.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K062479 · Joykey Industryial , Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
202d
Days
Class 2
Risk

K062479 is an FDA 510(k) clearance for the JOYKEY SURGICAL GOWNS (STERILE). Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Joykey Industryial , Ltd. (Flagstaff, US). The FDA issued a Cleared decision on March 14, 2007 after a review of 202 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 - K062479

510(k) Number K062479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2006
Decision Date March 14, 2007
Days to Decision 202 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
73d slower than avg
Panel avg: 129d · This submission: 202d
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 292
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K062479.
STRYKER STRI-SHIELD FLYTE TOGAS
K073017 · Stryker Instruments, Instruments Div. · Nov 2007
WELMED, INC. SURGICAL GOWNS
K070431 · Welmed, Inc. · May 2007
STRYKER T6 HOODS AND TOGAS
K063005 · Stryker Instruments · Mar 2007
STRYKER T4 HYTREL TOGA
K070078 · Stryker Instruments, Instruments Div. · Feb 2007
MICROTEK MEDICAL SURGICAL GOWN/TOGA
K062899 · Microtek Medical, Inc. · Jan 2007
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS
K062969 · Medline Industries, Inc. · Dec 2006
K062479 · JOYKEY SURGICAL GOWNS (STERILE)
Download PDF FDA Summary Joykey Industryial , …