N.S. Uni-Gloves Sdn. Bhd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “N.S. Uni-Gloves Sdn. Bhd.” (first 1989, latest 2005), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 54 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 4 | 4 |
| LZA | Polymer Patient Examination Glove | 3 | 3 |
Review panels
- General Hospital (7)
Most recent N.S. Uni-Gloves Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050765 | LANO-E POWDER-FREE NITRILE EXAMINATION GLOVE | LZA | 2005-04-08 | 15 |
| K013163 | UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES | LYY | 2002-01-22 | 123 |
| K010881 | UNIGLOVE POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | 2001-05-16 | 54 |
| K010879 | UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | 2001-05-10 | 48 |
| K000689 | UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES | LZA | 2000-04-28 | 59 |
| K000688 | UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES | LZA | 2000-04-12 | 43 |
| K890965 | PATIENT EXAMINATION GLOVES | LYY | 1989-04-28 | 60 |
Recalls
openFDA lists no recalls under a recalling firm named N.S. Uni-Gloves Sdn. Bhd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under N.S. Uni-Gloves Sdn. Bhd.?
FDA lists 7 510(k) clearances under the applicant name “N.S. Uni-Gloves Sdn. Bhd.” (first 1989, latest 2005), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by N.S. Uni-Gloves Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name N.S. Uni-Gloves Sdn. Bhd. is 54 days.
Which FDA product codes appear under N.S. Uni-Gloves Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 4); LZA (Polymer Patient Examination Glove, 3).
Next steps
- See all 7 N.S. Uni-Gloves Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LYY, N.S. Uni-Gloves Sdn. Bhd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.