510(k) Report

FDA applicant

Guilin Latex Factory

San Francisco, CA1 decision2000–20001 recall

FDA records 1 decision for Guilin Latex Factory (San Francisco, CA) in 2000: 1 510(k) clearance. All are in product code HIS (Condom). 1 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 Guilin Latex Factory’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Guilin Latex Factory since 2007.

Recalls per year

1in 2007

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

Class I Class II/III not classified

FIG. 1 — Guilin Latex Factory by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Guilin Latex Factory’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?

  • HISCondom1decision

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.

  • K994118Osmanthus, Kongfu, and Gobon, Natural Rubber Latex CondomsGuilin Latex Factory · 20001cites it

What has FDA decided for it lately?

  • K994118Osmanthus, Kongfu, and Gobon, Natural Rubber Latex CondomsGuilin Latex Factory · 20001 recall

The one decision as Guilin Latex Factory →

What has been recalled?

1 recall linked to its devices; the latest:

  • K994118Lubricated Latex Condom. Labeled in part: "COMING TOGETHER IN DC", Distributed by Global…Sep 11, 2007

Other applicant names beginning “Guilin”

FDA records each applicant name separately; these may or may not be the same firm.

Guilin Woodpecker Medical Instrument Co., Ltd. 14Guilin Kevin Peter Technology Co., Ltd. 4Guilin Refine Medical Instrument Co., Ltd. 3Guilin Hbm Health Protections, Inc. 2Guilin Hbm Sanitary Protections, Inc. 1Guilin Fourth Latex Plant 1Guilin Aesthedent Medical Instruments Co., Ltd. 1Guilin Fiteeth Medical Instrument Co., Ltd. 1