Cleared Traditional

K260725 - BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) (FDA 510(k) Clearance)

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

K260725 · Hindernis DE Mexico, S.A.P.I. DE C.V. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
68d
Days
Class 2
Risk

K260725 is an FDA 510(k) clearance for the BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10). Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Hindernis DE Mexico, S.A.P.I. DE C.V. (Naucalpan De Juarez, MX). The FDA issued a Cleared decision on May 12, 2026 after a review of 68 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 Hindernis DE Mexico, S.A.P.I. DE C.V. devices

Submission Details

510(k) Number K260725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2026
Decision Date May 12, 2026
Days to Decision 68 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
61d faster than avg
Panel avg: 129d · This submission: 68d
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 Consultant

Manton Business and Technology Services
Charles Shen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FYA Gown, Surgical

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