Data / Medical devices / Malaysia / Top Glove Sdn. Bhd.
Top Glove Sdn. Bhd.: FDA-registered device maker in KLANG Selangor, Malaysia, 6 510(k) clearances
Top Glove Sdn. Bhd. is registered with the FDA (registration 8043848) in KLANG Selangor, Malaysia. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated September 9, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8043848
- FEI number
- 3003564842
- Address
- Lot 4969,jalan Teratai,batu 6 Off Jalan Meru, KLANG Selangor, Malaysia, 41050
- Owner or operator
- TOP GLOVE SDN. BHD. (9004187)
- Roles
- Manufacturer
- First device listed
- December 6, 2012
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Manufacturer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 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 |
| Surgeon'S Gloves | KGO | 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 |
|---|---|---|---|---|---|---|
| September 9, 2026 | K262542 | Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim | LZA | Substantially Equivalent | Top Glove Sdn. Bhd. | accessdata.fda.gov |
| September 3, 2020 | K192111 | Biodegradable Nitrile Examination Powder Free Glove, Green | LZA | Substantially Equivalent | Top Glove Sdn. Bhd. | accessdata.fda.gov |
| June 5, 2020 | K193150 | Latex Examination Powder Free Glove, Aloe Vera | LZA | Substantially Equivalent | Top Glove Sdn. Bhd. | accessdata.fda.gov |
| April 26, 2018 | K172923 | Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue | LZA | Substantially Equivalent | Top Glove Sdn. Bhd. | accessdata.fda.gov |
| October 12, 2017 | K171279 | Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves | KGO | Substantially Equivalent | Top Glove Sdn. Bhd. | accessdata.fda.gov |
| November 30, 2012 | K122999 | POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | Top Glove Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Glove, Specialty
- All makers of Surgeon'S Gloves
- All makers of Polymer Patient Examination Glove
- All makers of Latex 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
Updated September 9, 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.