Home / 510(k) Clearances / K221570

510(k) K221570

Antibacterial bandage by Allmed Medical Products Co., Ltd. — Product Code FRO

K221570 is an FDA 510(k) premarket notification submitted by Allmed Medical Products Co., Ltd. for the device "Antibacterial bandage". The FDA issued a decision of Substantially Equivalent on September 29, 2023. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Allmed Medical Products Co., Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2023
Date Received
May 31, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Allmed Medical Products Co., Ltd.

  • K202128 — Allmed Surgical Face Masks (Ear loops) (June 3, 2021)
  • K202411 — Surgical Mask (March 10, 2021)
  • K202409 — Surgical Mask (March 9, 2021)

Other clearances for product code FRO

  • K261023 — Microdacyn Wound Irrigation Solution (June 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (June 24, 2026)
  • K261638 — Bonvadis® (June 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • K254191 — IWD-Gel™ (April 7, 2026)
  • K252023 — MiraChlor Antimicrobial Wound Solution (March 25, 2026)
  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (March 13, 2026)
  • K252028 — LUOFUCON® Antimicrobial Wound Gel (March 11, 2026)
  • K251582 — Redermax Antibacterial Wound Matrix (February 2, 2026)
  • K252568 — New Day Skin Spray (January 23, 2026)

FDA data resources