Cleared Traditional

Antibacterial Bandage (K221311) - FDA 510(k) Clearance

K221311 · Winner Medical Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
412d
Days
-
Risk

K221311 is an FDA 510(k) clearance for the Antibacterial Bandage. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Winner Medical Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 21, 2023 after a review of 412 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel. 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 & Plastic Surgery submissions.

View all Winner Medical Co., Ltd. devices

Submission Details

510(k) Number K221311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2022
Decision Date June 21, 2023
Days to Decision 412 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
297d slower than avg
Panel avg: 115d · This submission: 412d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 168
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K221311.
G4Derm / G4Derm Plus Synthetic Wound Matrix
K222025 · Gel4med, Inc. · Oct 2023
Antibacterial bandage
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K223526 · Smith & Nephew Medical Limited · Aug 2023
coactiv+™ Antimicrobial Wound Gel
K223259 · Kane Biotech, Inc. · May 2023
Antimicrobial Silicone PHMB Foam Wound Dressing
K223310 · Advanced Medical Solutions Limited · Apr 2023
BIASURGE Advanced Surgical Solution
K223377 · Rochal Technologies, LLC · Mar 2023