Hartalega Sdn Bhd
Hartalega Sdn Bhd has 0 FDA recalls, 0 inspections, 61 510(k) clearances and 0 compliance actions on record.
- Latest 510(k)
- Oct 2, 2020
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 61 | Oct 4, 2026 | Not stated | Current |
| Inspections | 0 | Oct 23, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K201748 | Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of… | Oct 2, 2020 |
| K201531 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl… | Aug 5, 2020 |
| K200897 | Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene… | Jun 1, 2020 |
| K180645 | Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs… | Nov 16, 2018 |
| K180786 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue… | Nov 2, 2018 |
| K173509 | Biodegradable Nitrile Powder Free Examination Glove (Blue) | Aug 17, 2018 |
| K180644 | Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green | Aug 10, 2018 |
| K180505 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim… | Jun 14, 2018 |
| K173137 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) | Dec 12, 2017 |
| K171874 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use… | Oct 12, 2017 |
| K170152 | POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN) | May 5, 2017 |
| K162491 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) | Feb 8, 2017 |
| K162818 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with… | Jan 9, 2017 |
| K162819 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy… | Jan 9, 2017 |
| K160560 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with… | Aug 4, 2016 |
| K161006 | Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or… | Aug 4, 2016 |
| K161008 | POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE | Jul 28, 2016 |
| K150593 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) | Jun 9, 2015 |
| K150103 | Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs | Apr 23, 2015 |
| K142588 | Nitrile Powder Free Examination Glove (Blue) | Dec 18, 2014 |