510(k) Report

FDA applicant

Shanghai Glovmax Enterprise Co.,Ltd

Taipei, TW4 decisions2000–20020 recalls

FDA records 4 decisions for Shanghai Glovmax Enterprise Co.,Ltd (Taipei, TW) from 2000 to 2002: 4 510(k) clearances. Most are in product codes LYZ (Vinyl Patient Examination Glove) and 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 Shanghai Glovmax Enterprise Co.,Ltd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shanghai Glovmax Enterprise Co.,Ltd since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Shanghai Glovmax Enterprise Co.,Ltd by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LYZVinyl Patient Examination Glove2decisions
  • 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?

  • K021000Shanghai Glovmax Enterprise Powdered Blue Nitrile Examination GlovesShanghai Glovmax Enterprise Co.,Ltd · 2002
  • K021001Shanghai Glovmax Enterprise Powderfree Blue Nitrile Examination GlovesShanghai Glovmax Enterprise Co.,Ltd · 2002
  • K993859Shanghai Glovmax Enterprise CO., LTD. Pre-Powdered Vinyl Patient Examination GlovesShanghai Glovmax Enterprise Co.,Ltd · 2000
  • K993880Shanghai Glovmax Enterprise CO, LTD., Powder-Free Vinyl Patient Examination GlovesShanghai Glovmax Enterprise Co.,Ltd · 2000

All 4 as Shanghai Glovmax Enterprise Co.,Ltd →