Professional Latex Sdn Bhd
Kamunting Perak, MY
PROFESSIONAL LATEX SDN BHD appears in FDA device records in Kamunting Perak, MY. FDA records list 3 510(k) clearances between and , no PMA records and 3 registered establishments. 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 3 510(k) clearances for Professional Latex Sdn Bhd between 2017 and 2023. The busiest year on record is 2017, with 1. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220088 | Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | |
| K173053 | POWDER FREE LATEX EXAMINATION GLOVE | LYY | Substantially Equivalent | |
| K171667 | Powder Free Nitrile Examination Glove | LZA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012924721 | 3012924721 | PROFESSIONAL LATEX SDN BHD | Lot 52, Jalan Logam 2, Kamunting Raya Industrial, Kamunting Perak 34600 MY | 2026 | |
| 3019585047 | 3019585047 | PROFESSIONAL LATEX SDN BHD | Lot 20734 & 20735, Lengkungan Perusahaan Kamunting 3/1, Kamunting Perak 34600 MY | 2026 | |
| 3042956952 | 3042956952 | PROFESSIONAL LATEX SDN. BHD. | LOT 14202, JALAN PERUSAHAAN 3,, KAMUNTING Perak 34600 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