N.S. Uni-Gloves Sdn. Bhd.
SEREMBAN Negeri Sembilan, MY
N.S. UNI-GLOVES SDN. BHD. appears in FDA device records in SEREMBAN Negeri Sembilan, MY. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for N.S. Uni-Gloves Sdn. Bhd. between 1989 and 2005. The busiest year on record is 2000, with 2. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 2000 | 2 |
| 2001 | 2 |
| 2002 | 1 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K050765 | LANO-E POWDER-FREE NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent | |
| K013163 | UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K010881 | UNIGLOVE POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | |
| K010879 | UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | |
| K000689 | UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K000688 | UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K890965 | PATIENT EXAMINATION GLOVES | LYY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8040880 | 3430 | N.S. UNI-GLOVES SDN. BHD. | LOT 3 & 4/4510 SENAWANG IND., SEREMBAN Negeri Sembilan 70450 MY | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain