Data / Medical devices / Malaysia / KSG Medicare Sdn Bhd
KSG Medicare Sdn Bhd: FDA-registered device maker in Tangkak Johor, Malaysia, 3 510(k) clearances
KSG Medicare Sdn Bhd is registered with the FDA (registration 3022407383) in Tangkak Johor, Malaysia. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 11, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022407383
- Address
- PTD 16063 (Lot 15295) Kawasan Perindustrian Tangkak, Tangkak Johor, Malaysia, 84900
- Owner or operator
- KSG Medicare Sdn Bhd (10084829)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 5, 2022
- Registered through
- 2026
- Brand names listed
- Polymer patient examination glove Patient examination glove, specialty Medical gloves with chemotherapy labeling claims, Powder Free Nitrile Examination Glove, Non-sterile (Blue)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 11, 2024 | K241745 | Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue) | LZA | Substantially Equivalent | Ksg Medicare Sdn. Bhd. | accessdata.fda.gov |
| April 11, 2022 | K220209 | Powder Free Nitrile Examination Glove, Non-sterile (Blue) | LZA | Substantially Equivalent | Ksg Medicare Sdn. Bhd. | accessdata.fda.gov |
| March 26, 2022 | K220215 | Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue) | LZA | Substantially Equivalent | Ksg Medicare Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
Updated September 11, 2024. 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.