Hwa Teh Industrial Sdn. Bhd.: FDA clearances and approvals
Hwa Teh Industrial Sdn. Bhd. has 6 FDA 510(k) clearances (first 1989, latest 2001), across 1 product code in 1 review panel. Median 510(k) review time: 35 days.
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 | 6 | 6 |
Review panels
- General Hospital (6)
Most recent Hwa Teh Industrial Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K010803 | POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR | LYY | 2001-05-11 | 56 |
| K000725 | HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) | LYY | 2000-04-05 | 30 |
| K994432 | HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (140 MICROGRAMS OR LESS) | LYY | 2000-02-16 | 48 |
| K992810 | HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE | LYY | 1999-09-27 | 38 |
| K992730 | HWA (AND) SILKTEX PRE-POWDERED LATEX EXAMINATION GLOVE | LYY | 1999-09-14 | 32 |
| K896251 | HWA TEH EXAMINATION GLOVES | LYY | 1989-11-21 | 22 |
Recalls
openFDA lists no recalls under a recalling firm named Hwa Teh Industrial 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 Hwa Teh Industrial Sdn. Bhd. have?
Hwa Teh Industrial Sdn. Bhd. has 6 FDA 510(k) clearances (first 1989, latest 2001), across 1 product code in 1 review panel.
How long does FDA take to clear Hwa Teh Industrial Sdn. Bhd.'s 510(k)s?
The median time from FDA receipt to decision across Hwa Teh Industrial Sdn. Bhd.'s cleared 510(k)s is 35 days.
What devices does Hwa Teh Industrial Sdn. Bhd. make?
Its most frequent FDA product codes are LYY (Latex Patient Examination Glove, 6).
Has Hwa Teh Industrial Sdn. Bhd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Hwa Teh Industrial Sdn. Bhd. Related entities may recall under other names.
Next steps
- See all 6 Hwa Teh Industrial Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Hwa Teh Industrial 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.