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510(k) K220133

Sterilization Wraps by Weihai Hongyu Nonwoven Fabric Products Co., Ltd. — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2022
Date Received
January 18, 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 Weihai Hongyu Nonwoven Fabric Products Co., Ltd.

  • K214088 — Disposable Surgical Gown (April 12, 2022)
  • K213029 — Nitrile Examination Gloves (Powder free, Blue) (December 14, 2021)
  • K212807 — Surgical Masks (December 3, 2021)
  • K141324 — HONGYU DISPOSABLE SURGICAL DRAPES (April 14, 2015)
  • K120192 — DISPOSABLE SURGICAL GOWNS (October 16, 2012)

Other clearances for product code FRG

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  • 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)