Smart Glove Corporation Sdn. Bhd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Smart Glove Corporation Sdn. Bhd.” (first 2017, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 195 days. Since 2017 the median was 195 days, against 116 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 |
|---|---|---|
| 2017 | 1 | 158 |
| 2018 | 1 | 195 |
| 2019 | 2 | 255 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 149 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Smart Glove Corporation Sdn. Bhd. took a median 195 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 3 | 3 |
| KGO | Surgeon'S Gloves | 2 | 2 |
Review panels
- General Hospital (5)
Most recent Smart Glove Corporation Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213373 | Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | 2022-03-10 | 149 |
| K183280 | PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs | LZA | 2019-07-26 | 245 |
| K181047 | Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs | KGO | 2019-01-09 | 265 |
| K180221 | Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs | KGO | 2018-08-08 | 195 |
| K171743 | Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves | LZA | 2017-11-17 | 158 |
Recalls
openFDA lists no recalls under a recalling firm named Smart Glove Corporation 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.
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.
- Smart Glove Corp. Sdn Bhd (27 510(k)s)
- Smart Medical Systems , Ltd. (9 510(k)s)
- Smart Soft Healthcare AD (3 510(k)s)
- Smart Alfa Teknoloji San. Ve Tic. A.S. (2 510(k)s)
- Smart Denture Conversions, LLC (2 510(k)s)
- Smart Performer Corp. , Ltd. (2 510(k)s)
- Smart Solutions Technologies SL (2 510(k)s)
- Smart Reactors (1 510(k)s)
- Smart Soft Healthcare (1 510(k)s)
- Smart Technology Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Smart Glove Corporation Sdn. Bhd.?
FDA lists 5 510(k) clearances under the applicant name “Smart Glove Corporation Sdn. Bhd.” (first 2017, latest 2022), 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 Smart Glove Corporation Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Smart Glove Corporation Sdn. Bhd. is 195 days. Since 2017: 195 days, versus 116 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Smart Glove Corporation Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 3); KGO (Surgeon'S Gloves, 2).
Next steps
- See all 5 Smart Glove Corporation Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Smart Glove Corporation 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.