Data / Medical devices / Polymer Patient Examination Glove / Malaysia
FDA-registered makers of Polymer Patient Examination Glove in Malaysia: 65 establishments
65 establishments in Malaysia are registered with the FDA to make Polymer Patient Examination Glove (product code LZA). 57 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Polymer Patient Examination Glove
- Product code
- LZA
- Country
- Malaysia
Makers of Polymer Patient Examination Glove in Malaysia
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Hartalega NGC Sdn. Bhd. (lot 39496) | Sepang Selangor, Malaysia | Manufacturer | 53 | January 8, 2025 | 0 | 0 | 0 | api.fda.gov |
| Hartalega NGC Sdn Bhd | Sepang Selangor, Malaysia | Contract manufacturer, Manufacturer | 36 | July 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| Hartalega Sdn Bhd | Bestari Jaya Selangor, Malaysia | Specification developer | 35 | August 5, 2020 | 0 | 0 | 0 | api.fda.gov |
| Kossan International Sdn Bhd | Shah Alam Selangor, Malaysia | Exporter to the US, Specification developer | 23 | January 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| WRP Asia Pacific Sdn. Bhd. | SALAK TINGGI, SEPANG Selangor, Malaysia | Complaint file establishment, Contract manufacturer, Manufacturer | 21 | November 17, 2023 | 0 | 0 | 0 | api.fda.gov |
| GX Corporation Sdn Bhd (Specialty Plant) | Klang Selangor, Malaysia | Contract manufacturer, Manufacturer | 16 | June 20, 2019 | 0 | 0 | 0 | api.fda.gov |
| Yty Industry (manjung) Sdn. Bhd. | SITIAWAN Perak, Malaysia | Contract manufacturer, Exporter to the US, Manufacturer | 16 | October 1, 2026 | 0 | 0 | 0 | api.fda.gov |
| Brightway Holdings Sdn. Bhd. | KLANG, Selangor, Malaysia | Exporter to the US, Manufacturer | 14 | November 2, 2022 | 0 | 0 | 0 | api.fda.gov |
| Eco Medi Glove Sdn Bhd | Taiping Perak, Malaysia | Contract manufacturer, Manufacturer | 14 | February 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Latexx Manufacturing Sdn. Bhd. | TAIPING Perak, Malaysia | Contract manufacturer, Manufacturer | 11 | January 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| TG Medical Sdn Bhd | KLANG Selangor, Malaysia | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler | 11 | September 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| Riverstone Resources Sdn Bhd | TAIPING Perak, Malaysia | Contract manufacturer, Manufacturer | 10 | June 3, 2022 | 0 | 0 | 0 | api.fda.gov |
| Central Medicare Sdn Bhd | Teluk Intan Perak, Malaysia | Contract manufacturer, Manufacturer | 9 | October 2, 2023 | 0 | 0 | 0 | api.fda.gov |
| GP Lumut | Sitiawan Perak, Malaysia | Contract manufacturer, Manufacturer, Specification developer | 8 | September 27, 2024 | 0 | 0 | 0 | api.fda.gov |
| Riverstone Resources Sdn. Bhd. | BUKIT BERUNTUNG, Selangor, Malaysia | Contract manufacturer, Manufacturer | 8 | April 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| Comfort Rubber Gloves Industries Sdn Bhd | TAIPING Perak, Malaysia | Manufacturer | 7 | June 19, 2020 | 0 | 0 | 0 | api.fda.gov |
| GMP Medicare Sdn Bhd(F25) | Klang Selangor, Malaysia | Contract manufacturer, Manufacturer | 6 | September 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| HL Rubber Industries Sdn Bhd | KUALA PILAH Negeri Sembilan, Malaysia | Contract manufacturer, Manufacturer | 6 | August 26, 2014 | 0 | 0 | 0 | api.fda.gov |
| Ansell Seremban Sdn. Bhd | Seremban Negeri Sembilan, Malaysia | Manufacturer | 5 | August 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| I Quality Rubber Industries Sdn. Bhd. | Matang Perak, Malaysia | Specification developer | 5 | September 20, 2017 | 0 | 0 | 0 | api.fda.gov |
| N.S. Uni-Gloves Sdn. Bhd. | SEREMBAN Negeri Sembilan, Malaysia | Manufacturer | 5 | March 21, 2012 | 0 | 0 | 0 | api.fda.gov |
| Top Glove Sdn. Bhd. | KLANG Selangor, Malaysia | Manufacturer | 5 | September 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ug Global Resources Sdn Bhd | Seremban Negeri Sembilan, Malaysia | Manufacturer | 5 | April 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| AIMAX HEALTHCARE SDN. BHD. (Formerly known as Hong Seng Gloves Sdn. Bhd.) | SUNGAI PETANI Kedah, Malaysia | Manufacturer | 4 | August 30, 2022 | 0 | 0 | 0 | api.fda.gov |
| Careglove Global Sdn Bhd | Seremban Negeri Sembilan, Malaysia | Contract manufacturer, Manufacturer | 4 | May 15, 2023 | 0 | 0 | 0 | api.fda.gov |
| Encompass Industries Sdn. Bhd. | KEMAMAN Terengganu, Malaysia | Contract manufacturer, Manufacturer, Repackager or relabeler | 4 | May 27, 2022 | 0 | 0 | 0 | api.fda.gov |
| JR Engineering And Medical Technologies (M) Sdn Bhd | RASA Selangor, Malaysia | Manufacturer | 4 | December 7, 2022 | 0 | 0 | 0 | api.fda.gov |
| Mah Sing Healthcare Sdn Bhd | Klang Selangor, Malaysia | Manufacturer | 4 | March 24, 2023 | 0 | 0 | 0 | api.fda.gov |
| Supermax Glove Manufacturing Sdn Bhd | SUNGAI BULOH Selangor, Malaysia | Manufacturer | 4 | January 10, 2003 | 0 | 0 | 0 | api.fda.gov |
| Gallant Quality Sdn. Bhd. | Taiping, Perak, Malaysia | Contract manufacturer, Manufacturer | 3 | October 9, 2015 | 0 | 0 | 0 | api.fda.gov |
| Koon Seng Sdn Bhd | Tangkak Johor, Malaysia | Contract manufacturer, Manufacturer | 3 | December 21, 2021 | 0 | 0 | 0 | api.fda.gov |
| KSG Medicare Sdn Bhd | Tangkak Johor, Malaysia | Contract manufacturer, Manufacturer | 3 | September 11, 2024 | 0 | 0 | 0 | api.fda.gov |
| Matang MFG. Sdn. Bhd. | MERLIMAU Melaka, Malaysia | Contract manufacturer, Manufacturer | 3 | October 17, 2012 | 0 | 0 | 0 | api.fda.gov |
| Multisafe Sdn Bhd | BIDOR Perak, Malaysia | Exporter to the US, Manufacturer | 3 | July 5, 2018 | 0 | 0 | 0 | api.fda.gov |
| Onetexx Sdn Bhd | Kamunting Perak, Malaysia | Contract manufacturer, Manufacturer | 3 | October 18, 2022 | 0 | 0 | 0 | api.fda.gov |
| Yty Acheh | Sitiawan Perak, Malaysia | Contract manufacturer, Manufacturer | 3 | September 27, 2024 | 0 | 0 | 0 | api.fda.gov |
| 3a Glove Sdn. Bhd. | Senai Johor, Malaysia | Contract manufacturer, Manufacturer | 2 | October 6, 2023 | 0 | 0 | 0 | api.fda.gov |
| Bergamot Sdn Bhd | KAJANG Selangor, Malaysia | Contract manufacturer, Exporter to the US | 2 | July 26, 2000 | 0 | 0 | 0 | api.fda.gov |
| Kossan Latex Industries (M) Sdn Bhd | KLANG Selangor, Malaysia | Contract manufacturer, Manufacturer | 2 | October 20, 2011 | 0 | 0 | 0 | api.fda.gov |
| Maxter Glove Manufacturing Sdn Bhd | KLANG Selangor, Malaysia | Manufacturer | 2 | February 6, 2012 | 0 | 0 | 0 | api.fda.gov |
| Maxwell Glove Manufacturing Bhd | KAMUNTING Perak, Malaysia | Manufacturer | 2 | May 19, 2005 | 0 | 0 | 0 | api.fda.gov |
| New Era Medicare Sdn Bhd | Teluk Intan Perak, Malaysia | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler | 2 | September 27, 2024 | 0 | 0 | 0 | api.fda.gov |
| Nitrilist Gloves Manufacturing Sdn Bhd | KUALA PILAH, Negeri Sembilan, Malaysia | Manufacturer | 2 | January 18, 2013 | 0 | 0 | 0 | api.fda.gov |
| Professional Latex Sdn Bhd | Kamunting Perak, Malaysia | Manufacturer | 2 | March 30, 2023 | 0 | 0 | 0 | api.fda.gov |
| Professional Latex Sdn Bhd | Kamunting Perak, Malaysia | Contract manufacturer, Manufacturer | 2 | September 8, 2017 | 0 | 0 | 0 | api.fda.gov |
| Professional Latex Sdn. Bhd. | KAMUNTING Perak, Malaysia | Manufacturer | 2 | March 30, 2023 | 0 | 0 | 0 | api.fda.gov |
| Tekmedic (M) Sdn Bhd | Melaka, Malaysia | Contract manufacturer, Manufacturer | 2 | January 18, 2013 | 0 | 0 | 0 | api.fda.gov |
| Aamedix Glove Sdn Bhd | Shah Alam Selangor, Malaysia | Complaint file establishment, Exporter to the US, Specification developer | 1 | April 11, 2022 | 0 | 0 | 0 | api.fda.gov |
| Dynacare Sdn Bhd | Sitiawan Perak, Malaysia | Manufacturer | 1 | January 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| Glovmaster Sdn. Bhd | BANTING Selangor, Malaysia | Manufacturer | 1 | December 22, 2021 | 0 | 0 | 0 | api.fda.gov |
| GMP Medicare Sdn Bhd | Siliau Negeri Sembilan, Malaysia | Manufacturer | 1 | February 24, 2021 | 0 | 0 | 0 | api.fda.gov |
| Pentavest Holdings Sdn Bhd | Batu Melaka, Malaysia | Manufacturer | 1 | January 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Perusahaan Getah Asas Sdn. Bhd. | JERAM Selangor, Malaysia | Contract manufacturer, Manufacturer | 1 | June 26, 2003 | 0 | 0 | 0 | api.fda.gov |
| Qube Medical Products Sdn Bhd | Rawang Selangor, Malaysia | Manufacturer | 1 | July 29, 2016 | 0 | 0 | 0 | api.fda.gov |
| Wear Safe (malaysia) Sdn Bhd | KLANG Selangor, Malaysia | Contract manufacturer, Manufacturer | 1 | October 27, 2006 | 0 | 0 | 0 | api.fda.gov |
| Wear Safe (malaysia) Sdn. Bhd. | KLANG Selangor, Malaysia | Contract manufacturer, Manufacturer | 1 | October 27, 2006 | 0 | 0 | 0 | api.fda.gov |
| Wear Safe (malaysia) Sdn. Bhd.-Facility Ii | Klang Selangor, Malaysia | Contract manufacturer, Manufacturer | 1 | February 19, 2013 | 0 | 0 | 0 | api.fda.gov |
| CM2 | Teluk Intan Perak, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eco Medi Glove Sdn Bhd | Taiping Perak, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eco Medi Glove Sdn Bhd | Taiping Perak, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ideal Quality Sdn Bhd | Klang Selangor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ideal Quality Sdn Bhd | KLANG Selangor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kl-Kepong Rubber Products Sdn. Bhd. | IPOH Perak, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pacewell Asia Sdn. Bhd. | Batu Gajah Perak, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Terang Nusa (malaysia) Sdn. Bhd. | Kota Bharu Kelantan, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.