Pwa Industries Sdn. Bhd.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Pwa Industries Sdn. Bhd.” (first 1995, latest 2001), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 49 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 | 8 | 8 |
| LZA | Polymer Patient Examination Glove | 3 | 3 |
Review panels
- General Hospital (11)
Most recent Pwa Industries Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011895 | POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES, POLYMER COATED ON OUTSIDE AND NITRILE COATED ON INSIDE, BLUE COLOR WITH | LYY | 2001-07-09 | 21 |
| K010077 | HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVES | LZA | 2001-02-28 | 49 |
| K001485 | HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE LATEX EXAMINATION GLOVES | LYY | 2000-06-13 | 32 |
| K001475 | HEALTH-PLUS, SANITEX, RELIANCE, POWDERED LATEX EXAM GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PR | LYY | 2000-06-13 | 33 |
| K981774 | MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE | LYY | 1998-07-24 | 65 |
| K973913 | MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE | LYY | 1997-12-18 | 65 |
| K973551 | MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE | LZA | 1997-11-06 | 48 |
| K972169 | MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE | LZA | 1997-10-03 | 116 |
| K964724 | POWDER-FREE LATEX EXAMINATION GLOVES | LYY | 1997-06-16 | 213 |
| K963560 | MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE | LYY | 1996-10-24 | 49 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Pwa Industries 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 Pwa Industries Sdn. Bhd.?
FDA lists 11 510(k) clearances under the applicant name “Pwa Industries Sdn. Bhd.” (first 1995, 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 Pwa Industries Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pwa Industries Sdn. Bhd. is 49 days.
Which FDA product codes appear under Pwa Industries Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 8); LZA (Polymer Patient Examination Glove, 3).
Next steps
- See all 11 Pwa Industries Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Pwa Industries 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.