510(k) Report

FDA applicant

P.T. Vonix Latexindo Condom (Rubber) Mfg.

Framingham, MA3 decisions2000–20000 recalls

FDA records 3 decisions for P.T. Vonix Latexindo Condom (Rubber) Mfg. (Framingham, MA) in 2000: 3 510(k) clearances. All are in product code HIS (Condom). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided P.T. Vonix Latexindo Condom (Rubber) Mfg.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for P.T. Vonix Latexindo Condom (Rubber) Mfg. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — P.T. Vonix Latexindo Condom (Rubber) Mfg. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like P.T. Vonix Latexindo Condom (Rubber)…’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?

  • HISCondom3decisions

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K993782Simplex Condoms, Latex Condoms-with Spermicidal Lubricant (Nonoxynol-9)P.T. Vonix Latexindo Condom (Rubber) Mfg. · 2000
  • K993779Simplex Condoms, Latex Condoms-Flavored and LubricatedP.T. Vonix Latexindo Condom (Rubber) Mfg. · 2000
  • K993781Simplex Condoms, Latex Condoms-Silicon LubricatedP.T. Vonix Latexindo Condom (Rubber) Mfg. · 2000

All 3 as P.T. Vonix Latexindo Condom (Rubber) Mfg. →