Innolatex Sdn. Bhd
PORT KLANG Selangor, MY
INNOLATEX SDN. BHD appears in FDA device records in PORT KLANG Selangor, MY. FDA records list 9 510(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 9 510(k) clearances for Innolatex Sdn. Bhd between 2000 and 2006. The busiest year on record is 2001, with 6. The most recent is 2006, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2001 | 6 |
| 2004 | 1 |
| 2006 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K053367 | MALE NATURAL RUBBER LATEX CONDOM | HIS | Substantially Equivalent | |
| K041837 | INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED | HIS | Substantially Equivalent | |
| K012964 | 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM | HIS | Substantially Equivalent | |
| K012962 | DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM | HIS | Substantially Equivalent | |
| K012665 | ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT | HIS | Substantially Equivalent | |
| K012664 | ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT | HIS | Substantially Equivalent | |
| K010919 | MALE NATURAL RUBBER LATEX CONDOM | HIS | Substantially Equivalent | |
| K010178 | SPERMICIDAL LUBRICATED MALE LATEX CONDOM | LTZ | Substantially Equivalent | |
| K002393 | NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM | HIS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9616515 | 3003117682 | INNOLATEX SDN. BHD | LOT 591 & 594, PERSIARAN RAJA LUMU, PORT KLANG Selangor 42000 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