Smart Glove Corp. Sdn Bhd: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Smart Glove Corp. Sdn Bhd” (first 1998, latest 2009), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 60 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 |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 16 | 16 |
| LYY | Latex Patient Examination Glove | 8 | 8 |
| KGO | Surgeon'S Gloves | 3 | 3 |
Review panels
- General Hospital (27)
Most recent Smart Glove Corp. Sdn Bhd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091147 | POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) | LZA | 2009-07-27 | 98 |
| K082370 | POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) | LZA | 2008-10-17 | 60 |
| K081466 | STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | LZA | 2008-07-30 | 64 |
| K071170 | POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL | LZA | 2007-09-14 | 140 |
| K063627 | POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) | LZA | 2007-03-20 | 104 |
| K061724 | POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE) | LZA | 2006-07-25 | 36 |
| K060726 | POWDER FREE NITRILE EXAMINATION GLOVE COATED WITH CUCUMBER WITH GLYCERINE (BLUE COLOR) | LZA | 2006-05-25 | 69 |
| K060724 | POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY) | LZA | 2006-05-17 | 61 |
| K050122 | POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE) | LZA | 2005-04-18 | 89 |
| K050598 | POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE) | LZA | 2005-04-07 | 29 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Smart Glove Corp. 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 Medical Systems , Ltd. (9 510(k)s)
- Smart Glove Corporation Sdn. Bhd. (5 510(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 Corp. Sdn Bhd?
FDA lists 27 510(k) clearances under the applicant name “Smart Glove Corp. Sdn Bhd” (first 1998, latest 2009), 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 Smart Glove Corp. Sdn Bhd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Smart Glove Corp. Sdn Bhd is 60 days.
Which FDA product codes appear under Smart Glove Corp. Sdn Bhd?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 16); LYY (Latex Patient Examination Glove, 8); KGO (Surgeon'S Gloves, 3).
Next steps
- See all 27 Smart Glove Corp. Sdn Bhd clearances with predicates and recalls
- Run predicate analysis for product code LZA, Smart Glove Corp. 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.