Antibacterial Bandage
K-Number: K221311 · 2023-06-21
ApplicantWinner Medical Co., Ltd.
Decision Date2023-06-21
Product CodeFRO
DecisionSubstantially Equivalent
Device Summary
Antibacterial Bandage is a medical device manufactured by Winner Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-06-21 under approval number K221311. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Antibacterial Bandage?
Antibacterial Bandage is a medical device that received FDA 510(k) clearance on 2023-06-21. It is manufactured by Winner Medical Co., Ltd.. The 510(k) number is K221311.
When was Antibacterial Bandage approved by the FDA?
Antibacterial Bandage received FDA 510(k) clearance on 2023-06-21, under approval number K221311.
What company makes Antibacterial Bandage?
Antibacterial Bandage is manufactured by Winner Medical Co., Ltd..
What is the FDA product code for Antibacterial Bandage?
The FDA product code for Antibacterial Bandage is FRO. This falls under the Anesthesiology category.
Other Devices by Winner Medical Co., Ltd.
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K192463PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border
K202982Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)
K221720Extra Silver Gelling Fiber Dressing
K22181935g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.