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510(k) K201324

Antibacterial Bandage by Jiangsu Excellence Medical Supplies Co., Ltd. — Product Code FRO

K201324 is an FDA 510(k) premarket notification submitted by Jiangsu Excellence Medical Supplies Co., Ltd. for the device "Antibacterial Bandage". The FDA issued a decision of Substantially Equivalent on Feb 5, 2021. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Jiangsu Excellence Medical Supplies Co., Ltd. has 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 5, 2021
Date Received
May 18, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Review Panel
SU
Submission Type
510(k)

Other clearances by Jiangsu Excellence Medical Supplies Co., Ltd.

  • K202905 — Disposable Face Mask (Mar 26, 2021)

Other clearances for product code FRO

  • K254041 — SkinSmart Antimicrobial HydroGel (Sep 11, 2026)
  • K261646 — Redermax® Antibacterial Wound Matrix (Aug 14, 2026)
  • K253665 — Vashe Plus Antimicrobial Solution (Aug 11, 2026)
  • K261023 — Microdacyn Wound Irrigation Solution (Jun 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (Jun 24, 2026)
  • K261638 — Bonvadis® (Jun 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • K254191 — IWD-Gel™ (Apr 7, 2026)
  • K252023 — MiraChlor Antimicrobial Wound Solution (Mar 25, 2026)
  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (Mar 13, 2026)

FDA data resources