Cleared Traditional

Sterile Level 3 Surgical Gown (K211399) - FDA 510(k) Clearance

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

K211399 · Barco Tekstil Sanayi VE Ticaret A.S. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
443d
Days
Class 2
Risk

K211399 is an FDA 510(k) clearance for the Sterile Level 3 Surgical Gown. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Barco Tekstil Sanayi VE Ticaret A.S. (Istanbul, TR). The FDA issued a Cleared decision on July 22, 2022 after a review of 443 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Barco Tekstil Sanayi VE Ticaret A.S. devices

Submission Details

510(k) Number K211399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2021
Decision Date July 22, 2022
Days to Decision 443 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
314d slower than avg
Panel avg: 129d · This submission: 443d
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

Medcer Uluslararasi Medikal Belgelendirme A.S.
Mehmet Fatih Örmeci

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

All 116
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