Shun Thai Rubber Gloves Industry Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Shun Thai Rubber Gloves Industry Co., Ltd.” (first 1989, latest 2005), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 59 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 | 5 | 5 |
| LZA | Polymer Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (6)
Most recent Shun Thai Rubber Gloves Industry Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051333 | NITRILE EXAMINATION GLOVES, POWDER FREE | LZA | 2005-07-22 | 60 |
| K982416 | SHUN-THAI - SAFE-CONTACT, BOSTON MEDICAL LATEX EXAM GLOVE, SHUN-THAI LATEX EXMINATION GLOVE | LYY | 1998-11-24 | 134 |
| K952695 | BOSTON MEDICAL LATEX EXAM GLOVES | LYY | 1995-08-11 | 58 |
| K930139 | HYPO-ALLERGENIC PATIENT EXAMINATION GLOVES | LYY | 1993-08-24 | 224 |
| K892554 | STERILE PATIENT EXAMINATION GLOVE | LYY | 1989-05-25 | 45 |
| K891300 | NON-STERILE PATIENT EXAMINATION GLOVE | LYY | 1989-04-05 | 23 |
Recalls
openFDA lists no recalls under a recalling firm named Shun Thai Rubber Gloves Industry 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.
- Shun Thai Rubber Gloves Industry Public Co., Ltd. (6 510(k)s)
- Shun DA (Xinghua) Co., Ltd. (2 510(k)s)
- Shun Tong Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shun Thai Rubber Gloves Industry Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Shun Thai Rubber Gloves Industry Co., Ltd.” (first 1989, latest 2005), 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 Shun Thai Rubber Gloves Industry Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shun Thai Rubber Gloves Industry Co., Ltd. is 59 days.
Which FDA product codes appear under Shun Thai Rubber Gloves Industry Co., Ltd.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 5); LZA (Polymer Patient Examination Glove, 1).
Next steps
- See all 6 Shun Thai Rubber Gloves Industry Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Shun Thai Rubber Gloves Industry 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.