Data / Medical devices / Malaysia / 3a Glove Sdn. Bhd.
3a Glove Sdn. Bhd.: FDA-registered device maker in Senai Johor, Malaysia, 2 510(k) clearances
3a Glove Sdn. Bhd. is registered with the FDA (registration 3025606191) in Senai Johor, Malaysia. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 6, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025606191
- Address
- PTD 114733, Jalan Cyber 4, Kawasan Perindustrian Senai (III), Senai Johor, Malaysia, 81400
- Owner or operator
- 3A Glove Sdn. Bhd. (10086871)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 4, 2023
- Registered through
- 2026
- Brand names listed
- Chemotherapy Gloves, Nitrile Exam Gloves - First Aid Only, Non Sterile, Single Use & Powder Free, Patient Examination Gloves
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 | 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 |
|---|---|---|---|---|---|---|
| October 6, 2023 | K230777 | Patient Examination Gloves | LZA | Substantially Equivalent | 3A Glove Sdn. Bhd. | accessdata.fda.gov |
| September 29, 2023 | K230847 | Chemotherapy Gloves | LZA | Substantially Equivalent | 3A Glove 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 Medical Glove, Specialty
Updated October 6, 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.