Data / Medical devices / Malaysia / Eco Medi Glove Sdn Bhd
Eco Medi Glove Sdn Bhd: FDA-registered device maker in Taiping Perak, Malaysia, 15 510(k) clearances
Eco Medi Glove Sdn Bhd is registered with the FDA (registration 3010763223) in Taiping Perak, Malaysia. It lists 4 device types. The FDA files 15 510(k) clearances under its listings, the newest dated February 26, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010763223
- Address
- Lot 23826,. Jalan Tembaga Kuning Kawasan Perindustrian Kamunting Raya, Taiping Perak, Malaysia, 34600
- Owner or operator
- ECO Medi Glove SDN BHD (10047533)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 3, 2014
- Registered through
- 2027
- Brand names listed
- Blue Nitrile Examination Gloves Powder free with tested for use with Chemotherapy Drugs Labeling Claim, Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim, Cardinal Health Nitrile Examination Glove Extended Cuff, Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim, EMG Blue Nitrile Examination Glove Powder Free with tested for used with Chemotherapy Drugs, EMG Pink Nitrile Examination Glove Powder Free, EMG Powder Free Nitrile Examination (Blue) Glove with Peppermint Scented, GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 26, 2024 | K233560 | Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid | LZA | Substantially Equivalent | Eco Medi Glove Sdn. Bhd. | accessdata.fda.gov |
| February 7, 2024 | K232764 | Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Eco Medi Glove Sdn. Bhd. | accessdata.fda.gov |
| December 28, 2023 | K233405 | Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim | LZA | Substantially Equivalent | Eco Medi Glove Sdn. Bhd. | accessdata.fda.gov |
| July 19, 2022 | K220943 | Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim | LZA | Substantially Equivalent | Eco Medi Glove Sdn. Bhd. | accessdata.fda.gov |
| March 20, 2020 | K193121 | GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims | LZA | Substantially Equivalent | Eco Medi Glove Sdn. Bhd. | accessdata.fda.gov |
| September 26, 2018 | K181066 | Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims | LZA | Substantially Equivalent | Eco Medi Glove Sdn. Bhd. | accessdata.fda.gov |
| July 7, 2017 | K171339 | EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs | LZA | Substantially Equivalent | Eco Medi Glove Sdn. Bhd. | accessdata.fda.gov |
| September 9, 2016 | K161187 | EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs | LZA | Substantially Equivalent | Eco Medi Glove Sdn. Bhd. | accessdata.fda.gov |
| September 1, 2016 | K161320 | EMG Pink Nitrile Examination Glove Powder Free | LZA | Substantially Equivalent | Eco Medi Glove Sdn. Bhd. | accessdata.fda.gov |
| June 23, 2016 | K152937 | EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented | LZA | Substantially Equivalent | Eco Medi Glove Sdn. Bhd. | accessdata.fda.gov |
| October 17, 2014 | K141579 | EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE | LZA | Substantially Equivalent | Eco Medi Glove Sdn. Bhd. | accessdata.fda.gov |
| October 7, 2014 | K141623 | EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM | LZA | Substantially Equivalent | Eco Medi Glove Sdn. Bhd. | accessdata.fda.gov |
| October 7, 2014 | K141510 | EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) | LZA | Substantially Equivalent | Eco Medi Glove Sdn. Bhd. | accessdata.fda.gov |
| September 3, 2014 | K141590 | EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE | LZA | Substantially Equivalent | Eco Medi Glove Sdn. Bhd. | accessdata.fda.gov |
| November 13, 2003 | K032444 | NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY | LZC | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
Updated February 26, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.