Cleared Traditional

K961341 - CONVERTORS POLYOLEFIN FABRIC GOWNS

K961341 is an FDA 510(k) clearance for CONVERTORS POLYOLEFIN FABRIC GOWNS, manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K961341 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
203d
Days
Class 2
Risk

K961341 is an FDA 510(k) clearance for the CONVERTORS POLYOLEFIN FABRIC GOWNS. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on October 28, 1996 after a review of 203 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.

View all Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K961341

510(k) Number K961341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1996
Decision Date October 28, 1996
Days to Decision 203 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
74d slower than avg
Panel avg: 129d · This submission: 203d
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 218
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K961341.
BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED NON-STERILE SURGICAL GOWN
K962666 · Bemiss-Jason Corp., Triad Medical Div. · Feb 1997
P1OP2B OR P1O92T
K954674 · Kay Borch A/S · Jan 1997
COOL-ZONE
K963809 · Kappler USA · Nov 1996
DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL
K961239 · Depuy, Inc. · Sep 1996
ROBISON & SMITH SURGICAL PACKS
K955586 · Robison & Smith, Inc. · Aug 1996
OREX SURGEON'S VEST
K961083 · Thantex Specialties, Inc. · Aug 1996