Latexx Manufacturing Sdn.Bhd.: FDA clearances and approvals
Latexx Manufacturing Sdn.Bhd. has 10 FDA 510(k) clearances (first 2002, latest 2012), across 3 product codes in 1 review panel. Median 510(k) review time: 76 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 590 |
| 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 | 7 | 7 |
| LYY | Latex Patient Examination Glove | 2 | 2 |
| LZC | Medical Glove, Specialty | 1 | 1 |
Review panels
- General Hospital (10)
Most recent Latexx Manufacturing Sdn.Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102189 | POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM | LZC | 2012-03-14 | 590 |
| K101645 | NON-CHLORINATED, POLYMER COATED POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES AND PROTEIN LABELING CLAIM OF | LYY | 2010-08-26 | 76 |
| K034052 | BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES | LZA | 2004-03-15 | 76 |
| K022346 | CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOLYMER EXAMINATION GLOVES | LZA | 2002-10-18 | 91 |
| K022102 | CLEANTEXX POWDERFREE BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVES, BLUE COLOUR | LZA | 2002-08-22 | 55 |
| K022548 | MEDTEXX BLUE COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES | LZA | 2002-08-15 | 14 |
| K022347 | MEDTEXX GREEN COLOUR POWDERED NITRILE RUBBER EXAMINATION GLOVES | LZA | 2002-08-15 | 27 |
| K022101 | MEDTEXX POWDERFREE NITRILE RUBBER EXAMINATION GLOVES, GREEN COLOUR | LZA | 2002-08-02 | 35 |
| K014087 | LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FREE RUBBER LATEX EXAMINATION GLOVE | LYY | 2002-03-04 | 83 |
| K013303 | CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO BUTADIENE CO-POLMER | LZA | 2002-01-23 | 111 |
Recalls
openFDA lists no recalls under a recalling firm named Latexx Manufacturing Sdn.Bhd..
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 Latexx Manufacturing Sdn.Bhd. have?
Latexx Manufacturing Sdn.Bhd. has 10 FDA 510(k) clearances (first 2002, latest 2012), across 3 product codes in 1 review panel.
How long does FDA take to clear Latexx Manufacturing Sdn.Bhd.'s 510(k)s?
The median time from FDA receipt to decision across Latexx Manufacturing Sdn.Bhd.'s cleared 510(k)s is 76 days.
What devices does Latexx Manufacturing Sdn.Bhd. make?
Its most frequent FDA product codes are LZA (Polymer Patient Examination Glove, 7); LYY (Latex Patient Examination Glove, 2); LZC (Medical Glove, Specialty, 1).
Has Latexx Manufacturing Sdn.Bhd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Latexx Manufacturing Sdn.Bhd. Related entities may recall under other names.
Next steps
- See all 10 Latexx Manufacturing Sdn.Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Latexx Manufacturing 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.