Seltom Pacific Sdn. Bhd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Seltom Pacific Sdn. Bhd.” (first 1999, latest 2001), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 78 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 Seltom Pacific Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011924 | POWDERED BLUE NITRILE EXAMINATION GLOVES | LZA | 2001-07-10 | 20 |
| K011922 | POWDERED LATEX EXAMINATION GLOVES | LYY | 2001-07-05 | 15 |
| K003934 | POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) | LYY | 2001-01-26 | 37 |
| K991778 | LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE) | LYY | 1999-08-31 | 98 |
| K991777 | LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL EXTRACTABLE PROTEIN) | LYY | 1999-08-31 | 98 |
| K991779 | NITRILE EXAMINATION GLOVES POWDER FREE (BLUE) | LZA | 1999-08-11 | 78 |
| K991776 | NITRILE EXAMINATION GLOVES POWDER FREE (WHITE) | LZA | 1999-08-11 | 78 |
Recalls
openFDA lists no recalls under a recalling firm named Seltom Pacific 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 Seltom Pacific Sdn. Bhd.?
FDA lists 7 510(k) clearances under the applicant name “Seltom Pacific Sdn. Bhd.” (first 1999, latest 2001), 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 Seltom Pacific Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Seltom Pacific Sdn. Bhd. is 78 days.
Which FDA product codes appear under Seltom Pacific 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 Seltom Pacific Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Seltom Pacific 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.