Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Pleasure Latex Products Sdn. Bhd. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
436 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022156 | LATEX ULTRASONIC PROBE COVER | Pleasure Latex Products Sdn. Bhd. | 2003-09-11 | 436 | 0 |
| K023333 | MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH | Pleasure Latex Products Sdn. Bhd. | 2003-06-23 | 259 | 0 |
| K021875 | MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WAL | Pleasure Latex Products Sdn. Bhd. | 2002-09-05 | 90 | 0 |
| K020272 | MALE LATEX CONDOM WITH RIBBED SURFACE | Pleasure Latex Products Sdn. Bhd. | 2002-04-26 | 88 | 0 |
| K002571 | MULITPLE MALE LATX CONDOM | Pleasure Latex Products Sdn. Bhd. | 2000-11-16 | 90 | 0 |
| K001377 | SPERMICIDAL LUBRICATED MALE LATEX CONDOM | Pleasure Latex Products Sdn. Bhd. | 2000-06-08 | 38 | 0 |
| K001221 | MALE LATEX COMDOM WITH DOTTED SURFACE | Pleasure Latex Products Sdn. Bhd. | 2000-05-19 | 32 | 0 |
| K994311 | MALE LATEX CONDOM WITH VANILLA FLAVOR | Pleasure Latex Products Sdn. Bhd. | 2000-03-21 | 90 | 0 |
| K994312 | MALE LATEX CONDOM 56MM | Pleasure Latex Products Sdn. Bhd. | 2000-03-21 | 90 | 0 |
| K982380 | SURE | Pleasure Latex Products Sdn. Bhd. | 1999-02-26 | 233 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda