510(k) Report

FDA applicant

Haining Medical Products Co., Ltd.

Tangshan, CN3 decisions2016–20180 recalls

FDA records 3 decisions for Haining Medical Products Co., Ltd. (Tangshan, CN) from 2016 to 2018: 3 510(k) clearances. All are in product code LZA (Polymer Patient Examination Glove). Since 2016 its 510(k)s took a median of 62 days from receipt to decision, against 178 for FDA’s reviews in the same codes and years. Its devices cite 3 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 Haining Medical Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2018

2016: 12018: 2
2016high 2 (2018) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Haining Medical Products Co., Ltd. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Haining Medical Products Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LZAPolymer Patient Examination Glove3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 62 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 178 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K183068Nitrile Glove Powder Free WhiteHaining Medical Products Co., Ltd. · 20181cites it

What has FDA decided for it lately?

  • K183068Nitrile Glove Powder Free WhiteHaining Medical Products Co., Ltd. · 2018
  • K182528Nitrile Glove Powder Free BlackHaining Medical Products Co., Ltd. · 2018
  • K152715Haining Nitrile Powder Free Patient Examination Gloves, Blue ColorHaining Medical Products Co., Ltd. · 2016

All 3 as Haining Medical Products Co., Ltd. →