Data / Medical devices / Malaysia / N.S. Uni-Gloves Sdn. Bhd.
N.S. Uni-Gloves Sdn. Bhd.: FDA-registered device maker in SEREMBAN Negeri Sembilan, Malaysia, 11 510(k) clearances
N.S. Uni-Gloves Sdn. Bhd. is registered with the FDA (registration 8040880) in SEREMBAN Negeri Sembilan, Malaysia. It lists 2 device types. The FDA files 11 510(k) clearances under its listings, the newest dated March 21, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8040880
- FEI number
- 3430
- Address
- Lot 3 & 4/4510 Senawang Ind. Estate, SEREMBAN Negeri Sembilan, Malaysia, 70450
- Owner or operator
- N.S. UNI-GLOVES SDN. BHD. (8040880)
- Roles
- Manufacturer
- First device listed
- November 5, 2007
- 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 |
|---|---|---|---|---|---|---|
| March 21, 2012 | K112012 | NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Ug Healthcare (Usa), Inc. | 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 16, 2001 | K010881 | UNIGLOVE POLYMER COATED 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 |
| 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 |
| August 5, 1997 | K971731 | UNIGLOVES | LYY | Substantially Equivalent | Uni-Glove (Usa), Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 21, 2012. 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.