510(k) Report

FDA applicant

Pleasure Latex Products Sdn. Bhd.

Jeram, Selangor Darul Ehsan, MY10 decisions1999–20030 recalls

FDA records 10 decisions for Pleasure Latex Products Sdn. Bhd. (Jeram, Selangor Darul Ehsan, MY) from 1999 to 2003: 10 510(k) clearances. Most are in product codes HIS (Condom) and LTZ (Condom With Nonoxynol-9). 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 Pleasure Latex Products Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pleasure Latex Products Sdn. Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Pleasure Latex Products Sdn. Bhd.’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?

  • HISCondom8decisions
  • LTZCondom With Nonoxynol-91decision
  • ITXTransducer, Ultrasonic, Diagnostic1decision

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.

  • K982380SUREPleasure Latex Products Sdn. Bhd. · 19991cites it

What has FDA decided for it lately?

  • K022156Latex Ultrasonic Probe CoverPleasure Latex Products Sdn. Bhd. · 2003
  • K023333Multiple, Male Latex Condom [52MM or 56MM Nominal Width with Smooth or Dotted or Ribbed or 3 in 1…Pleasure Latex Products Sdn. Bhd. · 2003
  • K021875Male Latex Condom with Dotted/Ribbed Surface and Counour-Walled Shape (3 in 1 Ultimate Male Latex CondomPleasure Latex Products Sdn. Bhd. · 2002
  • K020272Male Latex Condom with Ribbed SurfacePleasure Latex Products Sdn. Bhd. · 2002
  • K002571Mulitple Male Latx CondomPleasure Latex Products Sdn. Bhd. · 2000
  • K001377Spermicidal Lubricated Male Latex CondomPleasure Latex Products Sdn. Bhd. · 2000
  • K001221Male Latex Comdom with Dotted SurfacePleasure Latex Products Sdn. Bhd. · 2000
  • K994311Male Latex Condom with Vanilla FlavorPleasure Latex Products Sdn. Bhd. · 2000

All 10 as Pleasure Latex Products Sdn. Bhd. →