Data / Medical devices / Malaysia / AIMAX HEALTHCARE SDN. BHD. (Formerly known as Hong Seng Gloves Sdn. Bhd.)
AIMAX HEALTHCARE SDN. BHD. (Formerly known as Hong Seng Gloves Sdn. Bhd.): FDA-registered device maker in SUNGAI PETANI Kedah, Malaysia, 4 510(k) clearances
AIMAX HEALTHCARE SDN. BHD. (Formerly known as Hong Seng Gloves Sdn. Bhd.) is registered with the FDA (registration 3021233711) in SUNGAI PETANI Kedah, Malaysia. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 30, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3021233711
- Address
- Lot 97, Jalan 10, Kawasan Perusahaan Bakar Arang, SUNGAI PETANI Kedah, Malaysia, 08000
- Owner or operator
- AIMAX HEALTHCARE SDN. BHD. (10083806)
- Roles
- Manufacturer
- First device listed
- December 21, 2021
- Registered through
- 2026
- Brand names listed
- Powder Free Nitrile Examination Glove - Black, Non-Sterile, Powder Free Nitrile Examination Glove - Blue, Non Sterile, Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl, Powder Free Nitrile Examination Glove - White, Non-Sterile
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 |
|---|---|---|---|---|---|---|
| August 30, 2022 | K221164 | Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl | LZA | Substantially Equivalent | Hong Seng Gloves Sdn Bhd | accessdata.fda.gov |
| January 9, 2022 | K212801 | Powder free nitrile examination glove- black, non sterile | LZA | Substantially Equivalent | Hong Seng Gloves Sdn Bhd | accessdata.fda.gov |
| December 2, 2021 | K212802 | powder free nitrile examination glove - white, non-sterile | LZA | Substantially Equivalent | Hong Seng Gloves Sdn Bhd | accessdata.fda.gov |
| December 1, 2021 | K212804 | Powder free nitrile examination glove- blue, non-sterile | LZA | Substantially Equivalent | Hong Seng Gloves Sdn Bhd | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Glove, Specialty
Updated August 30, 2022. 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.