Data / Medical devices / Malaysia / Ug Global Resources Sdn Bhd
Ug Global Resources Sdn Bhd: FDA-registered device maker in Seremban Negeri Sembilan, Malaysia, 10 510(k) clearances
Ug Global Resources Sdn Bhd is registered with the FDA (registration 3010148335) in Seremban Negeri Sembilan, Malaysia. It lists 2 device types. The FDA files 10 510(k) clearances under its listings, the newest dated April 22, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010148335
- Address
- Lot 62 & 63, Lorong Senawang 3/2 Kawasan Perindustrian Senawang, Seremban Negeri Sembilan, Malaysia, 70450
- Owner or operator
- UG Global Resources Sdn Bhd (10042117)
- Roles
- Manufacturer
- First device listed
- November 22, 2013
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 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 |
|---|---|---|---|---|---|---|
| April 22, 2024 | K232319 | Black Pearl Nitrile Examination Glove | LZA | Substantially Equivalent | Ug Global Resources Sdn. Bhd. | accessdata.fda.gov |
| May 11, 2017 | K161961 | UniTex Non-Sterile, Powder-Free, Latex Examination Glove | LYY | Substantially Equivalent | Ug Global Resources Sdn. Bhd. | accessdata.fda.gov |
| October 15, 2010 | K101351 | NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT | LZA | Substantially Equivalent | Ascend Eagle, Inc. | accessdata.fda.gov |
| April 15, 2010 | K092472 | NON STERILE POWDER-FREE, NATURAL OR AQUA LANO-E NITRILE EXAMINATION GLOVES, WITH OR WITHOUT CITRUS/ PEPPERMINT SCENT | LZA | Substantially Equivalent | Ascend Eagle, Inc. | accessdata.fda.gov |
| November 30, 2006 | K062688 | POWDER-FREE BLACK LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM | LYY | Substantially Equivalent | Ug Healthcare (Usa), Inc. | accessdata.fda.gov |
| January 25, 2006 | K052666 | NON-STERILE POWDER FREE NATURAL/GREEN LANO-E LATEX EXAM GLOVES, WITH OR WIHOUT CITRUS/PEPPERMINT SCENT PLUS A PROTEIN | LYY | Substantially Equivalent | Ascend Eagle, Inc. | accessdata.fda.gov |
| April 8, 2005 | K050765 | LANO-E POWDER-FREE NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent | N.S. Uni-Gloves Sdn. Bhd. | accessdata.fda.gov |
| January 22, 2002 | K013163 | UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | N.S. Uni-Gloves Sdn. Bhd. | accessdata.fda.gov |
| May 10, 2001 | K010879 | UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | N.S. Uni-Gloves Sdn. Bhd. | accessdata.fda.gov |
| April 28, 2000 | K000689 | UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES | LZA | Substantially Equivalent | N.S. Uni-Gloves Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
Updated April 22, 2024. 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.