Grand Work Plastic Products Co., Ltd.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Grand Work Plastic Products Co., Ltd.” (first 2004, latest 2023), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 66 days. Since 2017 the median was 104 days, against 112 days for all cleared 510(k)s in the same product codes. 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 | 1 | 100 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 5 | 100 |
| 2023 | 3 | 107 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Grand Work Plastic Products Co., Ltd. took a median 104 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYZ | Vinyl Patient Examination Glove | 11 | 11 |
| LZA | Polymer Patient Examination Glove | 6 | 6 |
| KGO | Surgeon'S Gloves | 2 | 2 |
Review panels
- General Hospital (19)
Most recent Grand Work Plastic Products Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232444 | Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs | KGO | 2023-12-20 | 128 |
| K232039 | Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | 2023-08-09 | 30 |
| K230217 | Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs | KGO | 2023-05-13 | 107 |
| K222892 | Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs | LZA | 2022-12-15 | 83 |
| K213574 | Nitrile Vinyl Blend Powder Free Examination Gloves (Black) | LZA | 2022-07-12 | 244 |
| K220249 | Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue) | LZA | 2022-05-26 | 115 |
| K220250 | Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs | LZA | 2022-05-11 | 100 |
| K220240 | Vinyl Co-Polymer Powder-free Examination Gloves, Black | LYZ | 2022-03-31 | 62 |
| K142409 | Vinyl Co-Polymer Powder Free Examination Gloves | LYZ | 2014-12-05 | 100 |
| K102089 | GRAND WORK PLASTIC PRODUCTS CO., LTD. POWDER FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | 2010-10-06 | 62 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Grand Work Plastic Products 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.
- Grand Medical Products (8 510(k)s)
- Grand Monde Trading Co., Inc. (2 510(k)s)
- Grand Design Sdn. Bhd. (1 510(k)s)
- Grand Imperial, Inc. (1 510(k)s)
- Grand Seating King Corp. (1 510(k)s)
- Grand Traverse Technologies (1 510(k)s)
- Grand Universe Trading Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Grand Work Plastic Products Co., Ltd.?
FDA lists 19 510(k) clearances under the applicant name “Grand Work Plastic Products Co., Ltd.” (first 2004, latest 2023), 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 Grand Work Plastic Products Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Grand Work Plastic Products Co., Ltd. is 66 days. Since 2017: 104 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Grand Work Plastic Products Co., Ltd.?
The most frequent FDA product codes under this applicant name are LYZ (Vinyl Patient Examination Glove, 11); LZA (Polymer Patient Examination Glove, 6); KGO (Surgeon'S Gloves, 2).
Next steps
- See all 19 Grand Work Plastic Products Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LYZ, Grand Work Plastic Products 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.