510(k) Report

FDA applicant

Dehai (Shandong) Medical Gloves, Co., Ltd.

Zibo, CN2 decisions2013–20230 recalls

FDA records 2 decisions for Dehai (Shandong) Medical Gloves, Co., Ltd. (Zibo, CN) from 2013 to 2023: 2 510(k) clearances. All are in product code LZA (Polymer Patient Examination Glove). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 hospital panel, where it files most

How often FDA has decided Dehai (Shandong) Medical Gloves, Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2013: 12023: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Dehai (Shandong) Medical Gloves, Co., Ltd. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LZAPolymer Patient Examination Glove2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K232252Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black)…Dehai (Shandong) Medical Gloves, Co., Ltd. · 2023
  • K123869Powder-Free Nitrile Patient Examination GlovesDehai (Shandong) Medical Gloves, Co., Ltd. · 2013

All 2 as Dehai (Shandong) Medical Gloves, Co., Ltd. →