Hartalega Sdn Bhd
FDA 510(k) & PMA Approved Devices — 17 products
Total Devices17
Categories3
Latest Approval2020-10-02
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K201748 | Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs | KGO | 2020-10-02 | View |
| 510(k) | K201531 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | LZA | 2020-08-05 | View |
| 510(k) | K200897 | Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) | KGO | 2020-06-01 | View |
| 510(k) | K180645 | Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green) | LZA | 2018-11-16 | View |
| 510(k) | K180786 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff | LZA | 2018-11-02 | View |
| 510(k) | K173509 | Biodegradable Nitrile Powder Free Examination Glove (Blue) | LZA | 2018-08-17 | View |
| 510(k) | K180644 | Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green | LZA | 2018-08-10 | View |
| 510(k) | K180505 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White) | LZA | 2018-06-14 | View |
| 510(k) | K173137 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) | LZA | 2017-12-12 | View |
| 510(k) | K171874 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue) | LZA | 2017-10-12 | View |
| 510(k) | K170152 | POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN) | KGO | 2017-05-05 | View |
| 510(k) | K162491 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) | LZA | 2017-02-08 | View |
| 510(k) | K162818 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) | LZA | 2017-01-09 | View |
| 510(k) | K162819 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs | LZA | 2017-01-09 | View |
| 510(k) | K160560 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) | LZA | 2016-08-04 | View |
| 510(k) | K161006 | Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove | LYY | 2016-08-04 | View |
| 510(k) | K161008 | POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE | KGO | 2016-07-28 | View |
No matching devices.