Data / Medical devices / Surgeon'S Gloves / Malaysia
FDA-registered makers of Surgeon'S Gloves in Malaysia: 27 establishments
27 establishments in Malaysia are registered with the FDA to make Surgeon'S Gloves (product code KGO). 25 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Surgeon'S Gloves
- Product code
- KGO
- Country
- Malaysia
Makers of Surgeon'S Gloves in Malaysia
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| WRP Asia Pacific Sdn. Bhd. | SALAK TINGGI, SEPANG Selangor, Malaysia | Complaint file establishment, Contract manufacturer, Manufacturer | 34 | March 28, 2024 | 0 | 1 | 0 | api.fda.gov |
| Molnlycke Health Care SDN BHD | KULIM Kedah, Malaysia | Manufacturer | 16 | May 24, 2019 | 0 | 0 | 0 | api.fda.gov |
| Molnlycke Health Care Sdn. Bhd. | Kuala Ketil Kedah, Malaysia | Manufacturer | 16 | May 24, 2019 | 0 | 0 | 0 | api.fda.gov |
| Ansell N.P. Sdn. Bhd. | Melaka, Malaysia | Manufacturer | 14 | October 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| Molnlycke Health Care SDN BHD | Kulim Kedah, Malaysia | Manufacturer | 12 | May 24, 2019 | 0 | 0 | 0 | api.fda.gov |
| Hartalega NGC Sdn. Bhd. (lot 39496) | Sepang Selangor, Malaysia | Manufacturer | 11 | September 24, 2022 | 0 | 0 | 0 | api.fda.gov |
| Hartalega Sdn Bhd | Bestari Jaya Selangor, Malaysia | Specification developer | 8 | October 2, 2020 | 0 | 0 | 0 | api.fda.gov |
| Ansell Seremban Sdn. Bhd | Seremban Negeri Sembilan, Malaysia | Manufacturer | 7 | October 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| Hartalega NGC Sdn Bhd | Sepang Selangor, Malaysia | Manufacturer | 7 | July 28, 2026 | 0 | 0 | 0 | api.fda.gov |
| Brightway Holdings Sdn. Bhd. | KLANG, Selangor, Malaysia | Manufacturer | 4 | July 26, 1999 | 0 | 0 | 0 | api.fda.gov |
| JR Engineering And Medical Technologies (M) Sdn Bhd | RASA Selangor, Malaysia | Manufacturer | 2 | April 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| Latexx Manufacturing Sdn. Bhd. | TAIPING Perak, Malaysia | Contract manufacturer, Manufacturer | 2 | January 16, 2002 | 0 | 0 | 0 | api.fda.gov |
| Maxter Glove Manufacturing Sdn Bhd | KLANG Selangor, Malaysia | Manufacturer | 2 | October 17, 2003 | 0 | 0 | 0 | api.fda.gov |
| Supermax Glove Manufacturing Sdn Bhd | SUNGAI BULOH Selangor, Malaysia | Manufacturer | 2 | March 13, 2002 | 0 | 0 | 0 | api.fda.gov |
| TG Medical Sdn Bhd | KLANG Selangor, Malaysia | Contract manufacturer, Manufacturer, Repackager or relabeler | 2 | August 21, 2017 | 0 | 0 | 0 | api.fda.gov |
| Wear Safe (malaysia) Sdn Bhd | KLANG Selangor, Malaysia | Contract manufacturer, Manufacturer | 2 | September 29, 2017 | 0 | 0 | 0 | api.fda.gov |
| Careglove Global Sdn Bhd | Seremban Negeri Sembilan, Malaysia | Contract manufacturer, Manufacturer | 1 | December 30, 2019 | 0 | 0 | 0 | api.fda.gov |
| Central Medicare Sdn Bhd | Teluk Intan Perak, Malaysia | Manufacturer | 1 | January 26, 2023 | 0 | 0 | 0 | api.fda.gov |
| Eco Medi Glove Sdn Bhd | Taiping Perak, Malaysia | Manufacturer | 1 | February 17, 2021 | 0 | 0 | 0 | api.fda.gov |
| GMP Medicare Sdn Bhd(F25) | Klang Selangor, Malaysia | Manufacturer | 1 | May 23, 2000 | 0 | 0 | 0 | api.fda.gov |
| GX Corporation Sdn Bhd (Specialty Plant) | Klang Selangor, Malaysia | Contract manufacturer, Manufacturer | 1 | July 9, 2021 | 0 | 0 | 0 | api.fda.gov |
| Ineo Tech Sdn Bhd | Bandar Cassia Pulau Pinang, Malaysia | Manufacturer | 1 | September 29, 2023 | 0 | 0 | 0 | api.fda.gov |
| Pentavest Holdings Sdn Bhd | Batu Melaka, Malaysia | Manufacturer | 1 | December 27, 2021 | 0 | 0 | 0 | api.fda.gov |
| Top Glove Sdn. Bhd. | KLANG Selangor, Malaysia | Manufacturer | 1 | October 12, 2017 | 0 | 0 | 0 | api.fda.gov |
| Wear Safe (malaysia) Sdn. Bhd. | KLANG Selangor, Malaysia | Contract manufacturer, Manufacturer | 1 | May 15, 2009 | 0 | 0 | 0 | api.fda.gov |
| Encompass Industries Sdn. Bhd. | KEMAMAN Terengganu, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Terang Nusa (malaysia) Sdn. Bhd. | Kota Bharu Kelantan, Malaysia | Contract manufacturer | 0 | 0 | 2 | 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.