Cleared Traditional

K925715 - RS OPTIGUARD GOWN & DRAPE MATERIAL

K925715 is an FDA 510(k) clearance for RS OPTIGUARD GOWN & DRAPE MATERIAL, 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 180-day FDA review.

K925715 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
180d
Days
Class 2
Risk

K925715 is an FDA 510(k) clearance for the RS OPTIGUARD GOWN & DRAPE MATERIAL. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Waukegan, US). The FDA issued a Cleared decision on May 11, 1993 after a review of 180 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 - K925715

510(k) Number K925715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1992
Decision Date May 11, 1993
Days to Decision 180 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
51d slower than avg
Panel avg: 129d · This submission: 180d
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 K925715.
O.R./SURGEONS GOWN, ITEM NO. 4942
K921157 · The Sewing Source, Inc. · Jul 1993
O.R./SURGEONS GOWN, ITEM NO. 4950
K921158 · The Sewing Source, Inc. · Jul 1993
N-PAC STYLE C (D-STAT O.R. PROTECTIVE GOWN)
K932003 · National Healthcare Linen Service · Jun 1993
TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNS
K923815 · Laivan Corp. · Mar 1993
COMPEL XTR
K922753 · Standard Textile Co., Inc. · Mar 1993
COMPEL O AND R
K921889 · Standard Textile Co., Inc. · Feb 1993
K925715 · RS OPTIGUARD GOWN & DRAPE MATERIAL
Download PDF FDA Summary Baxter Healthcare Corp