Data / Medical devices / Malaysia / Mah Sing Healthcare Sdn Bhd
Mah Sing Healthcare Sdn Bhd: FDA-registered device maker in Klang Selangor, Malaysia, 4 510(k) clearances
Mah Sing Healthcare Sdn Bhd is registered with the FDA (registration 3017887964) in Klang Selangor, Malaysia. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 24, 2023. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3017887964
- Address
- Lot 6478, Lorong Sungai Puloh/ KU6 Kawasan Industri Sungai Puloh, Klang Selangor, Malaysia, 42100
- Owner or operator
- Mah Sing Healthcare Sdn Bhd (10079327)
- Roles
- Manufacturer
- First device listed
- September 15, 2022
- Registered through
- 2027
- Brand names listed
- Nitrile Powder Free Black Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs, Nitrile Powder Free Blue Examination Gloves, Non-Sterile, Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs, Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | 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 |
|---|---|---|---|---|---|---|
| March 24, 2023 | K230002 | Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Mah Sing Healthcare Sdn. Bhd. | accessdata.fda.gov |
| January 26, 2023 | K223415 | Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Mah Sing Healthcare Sdn. Bhd. | accessdata.fda.gov |
| February 19, 2022 | K214110 | Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs | LZA | Substantially Equivalent | Mah Sing Healthcare Sdn. Bhd. | accessdata.fda.gov |
| December 4, 2021 | K212535 | Nitrile Powder Free Blue Examination Gloves, Non-Sterile | LZA | Substantially Equivalent | Mah Sing Healthcare Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Glove, Specialty
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Polymer Patient Examination Glove
- All makers of Fentanyl And Other Opioid Protection Glove
Updated March 24, 2023. 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.