Terang Nusa Sdn Bhd: FDA clearances and approvals
Terang Nusa Sdn Bhd has 26 FDA 510(k) clearances (first 1989, latest 2017), across 3 product codes in 1 review panel. Median 510(k) review time: 78 days. openFDA lists 2 product recalls by a recalling firm named Terang Nusa Sdn Bhd.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 267 |
| 2015 | 1 | 115 |
| 2016 | 2 | 121 |
| 2017 | 1 | 70 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Terang Nusa Sdn Bhd's cleared 510(k)s took a median 70 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KGO | Surgeon'S Gloves | 15 | 15 |
| LYY | Latex Patient Examination Glove | 6 | 6 |
| LZA | Polymer Patient Examination Glove | 5 | 5 |
Review panels
- General Hospital (26)
Most recent Terang Nusa Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170779 | Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein | LYY | 2017-05-24 | 70 |
| K161932 | Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink | LZA | 2016-11-28 | 137 |
| K153510 | Powder Free Polychloroprene Examination Glove Green | LZA | 2016-03-21 | 105 |
| K151392 | Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less | KGO | 2015-09-18 | 115 |
| K140355 | SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT LABELING CLAIM | KGO | 2014-11-06 | 267 |
| K110698 | NUZONE X2T CHEMO, POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVES POWDER FREE | KGO | 2011-12-07 | 293 |
| K102230 | NUGARD NITILE GREY COLOR | LZA | 2010-09-10 | 32 |
| K102119 | SUR-G GLOV AND MAXITEX | KGO | 2010-08-27 | 30 |
| K083337 | NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES | LYY | 2009-01-27 | 76 |
| K052837 | SENSIFLEX PLUS POLYMER COATED LATEX POWDER-FREE SURGICAL GLOVE WITH ALOE VERA | KGO | 2005-11-21 | 46 |
16 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2006-12-18.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Terang Nusa Sdn Bhd have?
Terang Nusa Sdn Bhd has 26 FDA 510(k) clearances (first 1989, latest 2017), across 3 product codes in 1 review panel.
How long does FDA take to clear Terang Nusa Sdn Bhd's 510(k)s?
The median time from FDA receipt to decision across Terang Nusa Sdn Bhd's cleared 510(k)s is 78 days.
What devices does Terang Nusa Sdn Bhd make?
Its most frequent FDA product codes are KGO (Surgeon'S Gloves, 15); LYY (Latex Patient Examination Glove, 6); LZA (Polymer Patient Examination Glove, 5).
Has Terang Nusa Sdn Bhd had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Terang Nusa Sdn Bhd; the most recent began 2006-12-18. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 26 Terang Nusa Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code KGO, Terang Nusa Sdn Bhd's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.