Latexx Partners Bhd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Latexx Partners Bhd.” (first 1998, latest 2001), 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 |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 5 | 5 |
| LYY | Latex Patient Examination Glove | 2 | 2 |
Review panels
- General Hospital (7)
Most recent Latexx Partners Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011792 | NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES | LZA | 2001-08-01 | 54 |
| K011791 | POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR | LZA | 2001-08-01 | 54 |
| K992924 | QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOVES, POLYMER-COATED | LZA | 1999-11-05 | 67 |
| K992671 | QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES | LZA | 1999-09-24 | 45 |
| K991462 | QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED | LYY | 1999-05-28 | 31 |
| K981767 | QTEXX POWDERFREE LATEX EXAMINATION GLOVES | LYY | 1998-06-11 | 23 |
| K981159 | PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES | LZA | 1998-06-01 | 62 |
Recalls
openFDA lists no recalls under a recalling firm named Latexx Partners 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Latexx Manufacturing Sdn.Bhd. (10 510(k)s)
- Latexx Partners, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Latexx Partners Bhd.?
FDA lists 7 510(k) clearances under the applicant name “Latexx Partners Bhd.” (first 1998, 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 Latexx Partners Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Latexx Partners Bhd. is 54 days.
Which FDA product codes appear under Latexx Partners Bhd.?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 5); LYY (Latex Patient Examination Glove, 2).
Next steps
- See all 7 Latexx Partners Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Latexx Partners 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.