Cleared Traditional

K003749 - 100% 30G POLYPROPYLENE SPUNBOND ISLATIO...

K003749 is an FDA 510(k) clearance for 100% 30G POLYPROPYLENE SPUNBOND ISLATIO..., manufactured by Banta Healthcare. The device is a Class 2 General Hospital device with product code FYC cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K003749 · Banta Healthcare · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
81d
Days
Class 2
Risk

K003749 is an FDA 510(k) clearance for the 100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN. Classified as Gown, Isolation, Surgical (product code FYC), Class II - Special Controls.

Submitted by Banta Healthcare (Crofton, US). The FDA issued a Cleared decision on February 23, 2001 after a review of 81 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Banta Healthcare devices

FDA 510(k) Submission Details - K003749

510(k) Number K003749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2000
Decision Date February 23, 2001
Days to Decision 81 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 129d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYC Device Classification - Class 2, Special Controls

Product Code FYC Gown, Isolation, 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 - FYC Gown, Isolation, Surgical

All 34
Devices cleared under the same product code (FYC) and FDA review panel - the closest regulatory comparables to K003749.
SURGICAL ISOLATION GOWN
K171535 · Jingzhou Haixin Green Cross Medical Products Co., Ltd. · Feb 2018
Medline Non-Surgical Isolation Gown-
K160471 · Medline Industries, Inc. · Jan 2017
Cardinal Health Isolation Gown
K160339 · Cardinal Health200, LLC · Jul 2016
CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS
K982369 · Allegiance Healthcare Corp. · Aug 1998
BUSE STAFF PROTECTION GOWNS AND KITS
K941845 · Busse Hospital Disposables, Inc. · May 1995
ISOLATION GOWN
K874888 · Sage Products, Inc. · Dec 1987