510(k) Report

FDA applicant

Qingdao Shuang Die Latex Production Co.,Ltd

Durham, NC1 decision2001–20010 recalls

FDA records 1 decision for Qingdao Shuang Die Latex Production Co.,Ltd (Durham, NC) in 2001: 1 510(k) clearance. All are in product code HIS (Condom). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Qingdao Shuang Die Latex Production Co.,Ltd’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Qingdao Shuang Die Latex Production Co.,Ltd since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Qingdao Shuang Die Latex Production 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?

  • HISCondom1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K012653Male Latex CondomQingdao Shuang Die Latex Production Co.,Ltd · 2001

The one decision as Qingdao Shuang Die Latex Production Co.,Ltd →