Cleared Traditional

K032631 - INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X)

K032631 is an FDA 510(k) clearance for INNERBLOC LR SURGICAL GOWNS BASED ON GO..., manufactured by Lac Mac, Ltd.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K032631 · Lac Mac, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
163d
Days
Class 2
Risk

K032631 is an FDA 510(k) clearance for the INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X). Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Lac Mac, Ltd. (Austin, US). The FDA issued a Cleared decision on February 5, 2004 after a review of 163 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 - K032631

510(k) Number K032631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2003
Decision Date February 05, 2004
Days to Decision 163 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
34d slower than avg
Panel avg: 129d · This submission: 163d
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 269
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K032631.
PROMEDICAL SURGICAL GOWNS
K042111 · Promedical Products Co., Ltd. · Dec 2004
MAXAIR SURGICAL HELMET SYSTEM
K040485 · Bio-Medical Devices, Inc. · Oct 2004
STRYKER T4 HYTREL ZIPPER TOGA
K040764 · Stryker Corp. · Apr 2004
DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE
K033057 · Deroyal · Nov 2003
DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE)
K031408 · Deroyal · Oct 2003
MEDLINE REUSABLE SURGICAL GOWNS (100X)
K031933 · Medline Industries, Inc. · Sep 2003
K032631 · INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X)
Download PDF Lac Mac, Ltd.