FDA Device Intelligence
HomeFoshan Nanhai Plus Medical Co., Ltd › Plus Medical Isolation Gown Level 3

Plus Medical Isolation Gown Level 3

Foshan Nanhai Plus Medical Co., Ltd · Model PM4406FG · UDI-DI 06973062321335

FYC
1
510(k) clearances
28
Adverse events
2
Recalls
56
Facilities

Recalls

DateFirmReason
2024-11-01Cardinal Health 200, LLCIsolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancem
2024-11-01Cardinal Health 200, LLCIsolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancem

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.