Sterilization Wrap— 510(k) K223600

Clearance details

Applicant

Wuhan Zonsen Medical Products Co., Ltd.

Product code

Code FRG

Device class

Class 2

Regulation

21 CFR 880.6850

Advisory panel

General Hospital

Date received

2022-12-02

Decision date

2023-08-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Wuhan, CN

• K261897 — HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology +3 more2026-07-02
• K252823 — Dukal Crepe Paper Sterilization Wrap2026-05-28
• K253454 — HALYARD* ONE-STEP* Sterilization Wrap +3 more2026-05-18
• K251347 — Sterilization Pouch/Roll2026-01-28
• K251177 — Self-Seal Sterilization Pouch and Roll2025-12-12

• K213601 — Surgical Mask2022-12-16
• K213688 — Nitrile Examination Gloves (Model: ZMG1351)2022-02-18
• K212357 — Surgical isolation gown2022-01-20
• K212861 — Surgical Gown, Reinforced Surgical Gown2021-12-15
• K202191 — Surgical Mask2021-03-29

Other

3

Total

3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →