510(k) Report

FDA applicant

Kunshan Jiehong Nonwoven Product Co., Ltd.

San Diego, CA2 decisions2011–20110 recalls

FDA records 2 decisions for Kunshan Jiehong Nonwoven Product Co., Ltd. (San Diego, CA) in 2011: 2 510(k) clearances. Most are in product codes KKX (Drape, Surgical, Antimicrobial) and FYA (Gown, Surgical). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Kunshan Jiehong Nonwoven Product Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2011: 2
2011high 2 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Kunshan Jiehong Nonwoven Product Co., Ltd. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Kunshan”

FDA records each applicant name separately; these may or may not be the same firm.