Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)— 510(k) K182184

Name: FDA 510(k) clearance K182184
Creator: U.S. Food and Drug Administration
Published: 2019-10-10

Substantially Equivalent

Mdk (Shanghai) Medical Packing Co., Ltd.

FDA 510(k) clearance K182184 for Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted), Substantially Equivalent on 2019-10-10. Applicant: Mdk (Shanghai) Medical Packing Co., Ltd.. Device class: 2.

Clearance details

Applicant: Mdk (Shanghai) Medical Packing Co., Ltd.
Product code: Code FRG
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2018-08-13
Decision date: 2019-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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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

Adverse events under product code FRG

product code FRG

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.