Cleared Traditional

K911131 - STERILE SURGICAL GOWN PACK

K911131 is an FDA 510(k) clearance for STERILE SURGICAL GOWN PACK, manufactured by Central Georgia Ancillary Health Systems. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K911131 · Central Georgia Ancillary Health Systems · General Hospital
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Sep 1991
Decision
186d
Days
Class 2
Risk

K911131 is an FDA 510(k) clearance for the STERILE SURGICAL GOWN PACK. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Central Georgia Ancillary Health Systems (Macon, US). The FDA issued a Cleared decision on September 16, 1991 after a review of 186 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - 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 Central Georgia Ancillary Health Systems devices

FDA 510(k) Submission Details - K911131

510(k) Number K911131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1991
Decision Date September 16, 1991
Days to Decision 186 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 129d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKX Device Classification - Class 2, Special Controls

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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 - KKX Drape, Surgical

All 193
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K911131.
ARTHROSCOPY CAMERA DRAPE
K915214 · O.R. Concepts, Inc. · Jan 1992
QUALTEX MAGNETIC INSTRUMENT DRAPE
K914369 · Deroyal Industries, Inc. · Dec 1991
CONVERTORS SAFECARE GOWN & DRAPE MATERIAL
K913506 · Baxter Healthcare Corp · Oct 1991
CUSTOM PROCEDURE TRAY
K911565 · Vanguard Medical Concepts, Inc. · Aug 1991
PURITAS 100% COTTON ABSORB OPER ROOM SURG TOWELS
K912542 · Puritas Health Care, Inc. · Jul 1991
QUALTEX SURGICAL DRAPE
K910495 · Deroyal Industries, Inc. · Feb 1991