510(k) Report

FDA applicant

Beijing Reagent Latex Products Co., Ltd.

Crofton, MD4 decisions2001–20210 recalls

FDA records 4 decisions for Beijing Reagent Latex Products Co., Ltd. (Crofton, MD) from 2001 to 2021: 4 510(k) clearances. Most are in product codes KGO (Surgeon'S Gloves) and LZA (Polymer Patient Examination Glove). Its devices cite 1 predicate, 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 and plastic surgery panel, where it files most

How often FDA has decided Beijing Reagent Latex Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007: 12021: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Beijing Reagent Latex Products Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Beijing Reagent Latex 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.

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Which product codes does it file in?

  • KGOSurgeon'S Gloves2decisions
  • LZAPolymer Patient Examination Glove1decision
  • LYYLatex Patient Examination Glove1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K211515Nitrile Examination GlovesBeijing Reagent Latex Products Co., Ltd. · 20211cites it
  • K062797Powdered Latex Surgical GloveBeijing Reagent Latex Products Co., Ltd. · 20071cites it

What has FDA decided for it lately?

  • K211515Nitrile Examination GlovesBeijing Reagent Latex Products Co., Ltd. · 2021
  • K062797Powdered Latex Surgical GloveBeijing Reagent Latex Products Co., Ltd. · 2007
  • K012104Snow Lotus Powder-Free Latex Surgeon's GlovesBeijing Reagent Latex Products Co., Ltd. · 2001
  • K010947Snow Lotus Powder Free Latex Examination Gloves with a Protein Content Labeling Claim (50 Micrograms or Less)Beijing Reagent Latex Products Co., Ltd. · 2001

All 4 as Beijing Reagent Latex Products Co., Ltd. →