Cleared Traditional

K896935 - CONVERTORS BREATHABLE GOWN MATERIAL PRODUCT LINE

K896935 is an FDA 510(k) clearance for CONVERTORS BREATHABLE GOWN MATERIAL PRO..., 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 65-day FDA review.

K896935 · Baxter Healthcare Corp · General Hospital
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Feb 1990
Decision
65d
Days
Class 2
Risk

K896935 is an FDA 510(k) clearance for the CONVERTORS BREATHABLE GOWN MATERIAL PRODUCT LINE. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Niles, US). The FDA issued a Cleared decision on February 16, 1990 after a review of 65 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.

FDA 510(k) Submission Details - K896935

510(k) Number K896935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1989
Decision Date February 16, 1990
Days to Decision 65 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 129d · This submission: 65d
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 297
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K896935.
GOWN, OPERATING SURGICAL
K911568 · Huntsville Rehabilitation Foundation · Apr 1991
STERILE VIEW DISP. HOOD/GOWN UV, BARRIER HOOD, UV
K901536 · Depuy, Inc. · Nov 1990
SURGICAL GOWN, POLYULTRA(TM) FABRIC SYSTEM*
K902348 · Futuristic Medical Concepts, Inc. · Sep 1990
SHIRT, OPERATING, SURGICAL
K894599 · Miroz Industries Co. · Aug 1989
GOWN, OPERATING, SURGICAL
K894284 · Miroz Industries Co. · Jul 1989
NON-STERILE MASKS AND CAPS
K892118 · Paramount Products, Inc. · Apr 1989
K896935 · CONVERTORS BREATHABLE GOWN MATERIAL PRODUCT LINE
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