Data / Medical devices / Malaysia / Eco Medi Glove Sdn Bhd
Eco Medi Glove Sdn Bhd: FDA-registered device maker in Taiping Perak, Malaysia, 1 510(k) clearance
Eco Medi Glove Sdn Bhd is registered with the FDA (registration 3016413634) in Taiping Perak, Malaysia. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 17, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3016413634
- Address
- Lot 26910, Lorong Perusahaan 3/3 Kawasan Perusahaan, Kamunting Raya, Taiping Perak, Malaysia, 34600
- Owner or operator
- Eco Medi Glove Sdn Bhd (10061572)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 30, 2019
- Registered through
- 2027
- Brand names listed
- Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim, Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim, Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl test claim
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract 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 |
|---|---|---|---|---|---|---|
| February 17, 2021 | K202401 | Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein | KGO | Substantially Equivalent | Eco Medi Glove 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 Surgeon'S Gloves
Updated February 17, 2021. 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.