Eco Medi Glove Sdn. Bhd.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Eco Medi Glove Sdn. Bhd.” (first 2014, latest 2024), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 120 days. Since 2017 the median was 120 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 |
|---|---|---|
| 2014 | 4 | 116 |
| 2015 | 0 | — |
| 2016 | 3 | 135 |
| 2017 | 1 | 60 |
| 2018 | 1 | 156 |
| 2019 | 0 | — |
| 2020 | 1 | 129 |
| 2021 | 1 | 180 |
| 2022 | 1 | 110 |
| 2023 | 1 | 84 |
| 2024 | 2 | 132 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Eco Medi Glove Sdn. Bhd. took a median 120 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 | 14 | 14 |
| KGO | Surgeon'S Gloves | 1 | 1 |
Review panels
- General Hospital (15)
Most recent Eco Medi Glove Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233560 | Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid | LZA | 2024-02-26 | 112 |
| K232764 | Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | 2024-02-07 | 152 |
| K233405 | Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim | LZA | 2023-12-28 | 84 |
| K220943 | Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim | LZA | 2022-07-19 | 110 |
| K202401 | Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein | KGO | 2021-02-17 | 180 |
| K193121 | GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims | LZA | 2020-03-20 | 129 |
| K181066 | Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims | LZA | 2018-09-26 | 156 |
| K171339 | EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs | LZA | 2017-07-07 | 60 |
| K161187 | EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs | LZA | 2016-09-09 | 135 |
| K161320 | EMG Pink Nitrile Examination Glove Powder Free | LZA | 2016-09-01 | 113 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Eco Medi Glove 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Eco Medi Glove Sdn. Bhd.?
FDA lists 15 510(k) clearances under the applicant name “Eco Medi Glove Sdn. Bhd.” (first 2014, latest 2024), 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 Eco Medi Glove Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Eco Medi Glove Sdn. Bhd. is 120 days. Since 2017: 120 days, versus 116 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Eco Medi Glove Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 14); KGO (Surgeon'S Gloves, 1).
Next steps
- See all 15 Eco Medi Glove Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Eco Medi Glove 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.