Pleasure Latex Products Sdn. Bhd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Pleasure Latex Products Sdn. Bhd.” (first 1999, latest 2003), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HIS | Condom | 8 | 8 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| LTZ | Condom With Nonoxynol-9 | 1 | 1 |
Review panels
Most recent Pleasure Latex Products Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022156 | LATEX ULTRASONIC PROBE COVER | ITX | 2003-09-11 | 436 |
| K023333 | MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR | HIS | 2003-06-23 | 259 |
| K021875 | MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1 ULTIMATE MALE LATEX CONDOM | HIS | 2002-09-05 | 90 |
| K020272 | MALE LATEX CONDOM WITH RIBBED SURFACE | HIS | 2002-04-26 | 88 |
| K002571 | MULITPLE MALE LATX CONDOM | HIS | 2000-11-16 | 90 |
| K001377 | SPERMICIDAL LUBRICATED MALE LATEX CONDOM | LTZ | 2000-06-08 | 38 |
| K001221 | MALE LATEX COMDOM WITH DOTTED SURFACE | HIS | 2000-05-19 | 32 |
| K994312 | MALE LATEX CONDOM 56MM | HIS | 2000-03-21 | 90 |
| K994311 | MALE LATEX CONDOM WITH VANILLA FLAVOR | HIS | 2000-03-21 | 90 |
| K982380 | SURE | HIS | 1999-02-26 | 233 |
Recalls
openFDA lists no recalls under a recalling firm named Pleasure Latex Products Sdn. Bhd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Pleasure Latex Products Sdn. Bhd.?
FDA lists 10 510(k) clearances under the applicant name “Pleasure Latex Products Sdn. Bhd.” (first 1999, latest 2003), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Pleasure Latex Products Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pleasure Latex Products Sdn. Bhd. is 90 days.
Which FDA product codes appear under Pleasure Latex Products Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are HIS (Condom, 8); ITX (Transducer, Ultrasonic, Diagnostic, 1); LTZ (Condom With Nonoxynol-9, 1).
Next steps
- See all 10 Pleasure Latex Products Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code HIS, Pleasure Latex Products Sdn. Bhd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.