Modern Rubber Industrial Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Modern Rubber Industrial Co., Ltd.” (first 1989, latest 1990), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 66 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 | 3 | 3 |
| LYY | Latex Patient Examination Glove | 2 | 2 |
Review panels
- General Hospital (5)
Most recent Modern Rubber Industrial Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K900669 | HYPO-ALLERGENIC SURGICAL GLOVES | KGO | 1990-04-16 | 66 |
| K893492 | LATEX EXAMINATION GLOVES | LYY | 1989-08-24 | 112 |
| K892056 | SURGICAL LATEX STERILE GLOVES | KGO | 1989-06-08 | 76 |
| K892064 | LATEX SURGICAL GLOVES,STERILE/NON STERILE MOD BRAN | KGO | 1989-04-26 | 27 |
| K891065 | LATEX EXAMINATION GLOVES | LYY | 1989-03-16 | 15 |
Recalls
openFDA lists no recalls under a recalling firm named Modern Rubber Industrial Co., 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.
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.
- Modern Medical Equipment Mfg., Ltd. (14 510(k)s)
- Modern Diagnostics, Inc. (5 510(k)s)
- Modern Medical Equipment Manufacturing, Ltd. (4 510(k)s)
- Modern Medical Equipment Manufacturing Limited (4 510(k)s)
- Modern Healthcare Corp. (3 510(k)s)
- Modern Dental Laboratory (Dg) Co., Ltd. (2 510(k)s)
- Modern Engineering Co., Inc. (2 510(k)s)
- Modern Materials (2 510(k)s)
- Modern Medical Systems Co. (2 510(k)s)
- Modern Systems Technology, Inc. (2 510(k)s)
- Modern Health Care Products (1 510(k)s)
- Modern Korea Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Modern Rubber Industrial Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Modern Rubber Industrial Co., Ltd.” (first 1989, latest 1990), 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 Modern Rubber Industrial Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Modern Rubber Industrial Co., Ltd. is 66 days.
Which FDA product codes appear under Modern Rubber Industrial Co., Ltd.?
The most frequent FDA product codes under this applicant name are KGO (Surgeon'S Gloves, 3); LYY (Latex Patient Examination Glove, 2).
Next steps
- See all 5 Modern Rubber Industrial Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KGO, Modern Rubber Industrial Co., 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.