Pleasure Latex Products Sdn. Bhd.
JERAM Selangor, MY
PLEASURE LATEX PRODUCTS SDN. BHD. appears in FDA device records in JERAM Selangor, MY. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Pleasure Latex Products Sdn. Bhd. between 1999 and 2003. The busiest year on record is 2000, with 5. The most recent is 2003, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2000 | 5 |
| 2002 | 2 |
| 2003 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K022156 | LATEX ULTRASONIC PROBE COVER | ITX | Substantially Equivalent | |
| K023333 | MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR | HIS | Substantially Equivalent | |
| K021875 | MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1 ULTIMATE MALE LATEX CONDOM | HIS | Substantially Equivalent | |
| K020272 | MALE LATEX CONDOM WITH RIBBED SURFACE | HIS | Substantially Equivalent | |
| K002571 | MULITPLE MALE LATX CONDOM | HIS | Substantially Equivalent | |
| K001377 | SPERMICIDAL LUBRICATED MALE LATEX CONDOM | LTZ | Substantially Equivalent | |
| K001221 | MALE LATEX COMDOM WITH DOTTED SURFACE | HIS | Substantially Equivalent | |
| K994312 | MALE LATEX CONDOM 56MM | HIS | Substantially Equivalent | |
| K994311 | MALE LATEX CONDOM WITH VANILLA FLAVOR | HIS | Substantially Equivalent | |
| K982380 | SURE | HIS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9613994 | 3009084570 | PLEASURE LATEX PRODUCTS SDN. BHD. | LOT 5322, 15TH MILES, JERAM Selangor 45800 MY | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain