Cleared Traditional

K010799 - COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE) (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K010799 · Standard Textile Co., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
83d
Days
Class 2
Risk

K010799 is an FDA 510(k) clearance for the COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE). Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Standard Textile Co., Inc. (Cincinnati, US). The FDA issued a Cleared decision on June 7, 2001 after a review of 83 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 Standard Textile Co., Inc. devices

Submission Details

510(k) Number K010799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2001
Decision Date June 07, 2001
Days to Decision 83 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 128d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 292
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K010799.
Cardinal Health™ Poly Reinforced Surgical Gown
K253243 · Cardinal Health 200, LLC · Apr 2026
Non-sterile Level 3 Surgical Gown (4025)
K253003 · Hubei Xinxin Non-Woven Co., Ltd. · Apr 2026
Copioumed AAMI 3 Surgical Gown
K251860 · Copioumed International, Inc. · Feb 2026
Henan Yadu Level 4 Surgical Gowns (Reinforced)
K252301 · Yadu Medical (Henan) Co., Ltd. · Feb 2026
Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL)
K250564 · Yadu Medical (Henan) Co., Ltd. · Dec 2025
ViVi® Toga Premium
K243522 · Thi Total Healthcare Innovation GmbH · May 2025