Home / 510(k) Clearances / K223600

510(k) K223600

Sterilization Wrap by Wuhan Zonsen Medical Products Co., Ltd. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2023
Date Received
December 2, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

Other clearances by Wuhan Zonsen Medical Products Co., Ltd.

  • K213601 — Surgical Mask (December 16, 2022)
  • K213688 — Nitrile Examination Gloves (Model: ZMG1351) (February 18, 2022)
  • K212357 — Surgical isolation gown (January 20, 2022)
  • K212861 — Surgical Gown, Reinforced Surgical Gown (December 15, 2021)
  • K202191 — Surgical Mask (March 29, 2021)

Other clearances for product code FRG

  • K251347 — Sterilization Pouch/Roll (January 28, 2026)
  • K251177 — Self-Seal Sterilization Pouch and Roll (December 12, 2025)
  • K250306 — Chex-All Sterilization Pouches and Tubes (October 31, 2025)
  • K243179 — Sterilization Pouch and Roll (June 26, 2025)
  • K250321 — GCI Sterilization Wrappers (June 6, 2025)
  • K243721 — Self Sealing Sterilization Pouches (April 25, 2025)
  • K250011 — Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS120 (April 4, 2025)
  • K241565 — Sterilization Package/Reel (February 24, 2025)
  • K243431 — Medicom Sterilization Pouch and Reel (February 21, 2025)
  • K242898 — Sterilization Pouches and Reels (February 21, 2025)