Sri Anusham Rubber Industries Pvt., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Sri Anusham Rubber Industries Pvt., Ltd.” (first 1992, latest 1999), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 61 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 |
|---|---|---|---|
| KGO | Surgeon'S Gloves | 2 | 2 |
| LYY | Latex Patient Examination Glove | 2 | 2 |
| LZA | Polymer Patient Examination Glove | 2 | 2 |
Review panels
- General Hospital (6)
Most recent Sri Anusham Rubber Industries Pvt., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993349 | NIL, SURGEON'S GLOVE - POWDER FREE | KGO | 1999-11-23 | 49 |
| K993348 | NIL, NITRILE EXAMINATION GLOVE - POWDER FREE | LZA | 1999-11-19 | 45 |
| K993347 | NIL, NITRILE EXAMINATION GLOVE - POWDERED | LZA | 1999-11-19 | 45 |
| K984395 | SURGEON'S GLOVES | KGO | 1999-05-21 | 164 |
| K983998 | POWDER FREE LATEX EXAMINATION GLOVES | LYY | 1999-01-21 | 73 |
| K915872 | LATEX PATIENT EXAMINATION GLOVES | LYY | 1992-04-02 | 119 |
Recalls
openFDA lists no recalls under a recalling firm named Sri Anusham Rubber Industries Pvt., Ltd..
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 Sri Anusham Rubber Industries Pvt., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Sri Anusham Rubber Industries Pvt., Ltd.” (first 1992, latest 1999), across 3 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 Sri Anusham Rubber Industries Pvt., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sri Anusham Rubber Industries Pvt., Ltd. is 61 days.
Which FDA product codes appear under Sri Anusham Rubber Industries Pvt., Ltd.?
The most frequent FDA product codes under this applicant name are KGO (Surgeon'S Gloves, 2); LYY (Latex Patient Examination Glove, 2); LZA (Polymer Patient Examination Glove, 2).
Next steps
- See all 6 Sri Anusham Rubber Industries Pvt., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KGO, Sri Anusham Rubber Industries Pvt., Ltd.'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.