FDA 510(k) Applications Submitted by Winner Medical Co., Ltd.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K191819 |
07/05/2019 |
Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border |
Winner Medical Co., Ltd. |
| K192463 |
09/09/2019 |
PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border |
Winner Medical Co., Ltd. |
| K210466 |
02/16/2021 |
Silver Gelling Fiber Dressing |
Winner Medical Co., Ltd. |
| K202982 |
09/30/2020 |
Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) |
Winner Medical Co., Ltd. |
| K220194 |
01/24/2022 |
Procedure mask/Surgical mask/Face mask |
Winner Medical Co., Ltd. |
| K221720 |
06/13/2022 |
Extra Silver Gelling Fiber Dressing |
Winner Medical Co., Ltd. |
| K221819 |
06/23/2022 |
35g 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 |
Winner Medical Co., Ltd. |
| K223232 |
10/19/2022 |
Procedure mask/Surgical mask/Face mask |
Winner Medical Co., Ltd. |
| K221311 |
05/05/2022 |
Antibacterial Bandage |
Winner Medical Co., Ltd. |
| K221532 |
05/26/2022 |
PHMB Wound Dressing |
Winner Medical Co., Ltd. |
| K221754 |
06/16/2022 |
Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC) |
Winner Medical Co., Ltd. |
| K221755 |
06/16/2022 |
Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing |
Winner Medical Co., Ltd. |
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