Company ยท MY
Hartalega Sdn Bhd
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2020. Name variants (Inc, Corp, punctuation) are merged.
61510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 2, 2020 | K201748 | Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for u Hartalega Sdn Bhd, MY | KGO |
| Aug 5, 2020 | K201531 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Hartalega Sdn Bhd, MY | LZA |
| Jun 1, 2020 | K200897 | Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical G Hartalega Sdn Bhd, MY | KGO |
| Nov 16, 2018 | K180645 | Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green) Hartalega Sdn Bhd, MY | LZA |
| Nov 2, 2018 | K180786 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile P Hartalega Sdn Bhd, MY | LZA |
| Aug 17, 2018 | K173509 | Biodegradable Nitrile Powder Free Examination Glove (Blue) Hartalega Sdn Bhd, MY | LZA |
| Aug 10, 2018 | K180644 | Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green Hartalega Sdn Bhd, MY | LZA |
| Jun 14, 2018 | K180505 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use Hartalega Sdn Bhd, MY | LZA |
| Dec 12, 2017 | K173137 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) Hartalega Sdn Bhd, MY | LZA |
| Oct 12, 2017 | K171874 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Dr Hartalega Sdn Bhd, MY | LZA |
| May 5, 2017 | K170152 | POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN) Hartalega Sdn Bhd, MY | KGO |
| Feb 8, 2017 | K162491 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) Hartalega Sdn Bhd, MY | LZA |
| Jan 9, 2017 | K162819 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs Hartalega Sdn Bhd, MY | LZA |
| Jan 9, 2017 | K162818 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Bl Hartalega Sdn Bhd, MY | LZA |
| Aug 4, 2016 | K161006 | Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove Hartalega Sdn Bhd, MY | LYY |
| Aug 4, 2016 | K160560 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Bl Hartalega Sdn Bhd, MY | LZA |
| Jul 28, 2016 | K161008 | POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE Hartalega Sdn Bhd, MY | KGO |
| Jun 9, 2015 | K150593 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) Hartalega Sdn Bhd, MY | LZA |
| Apr 23, 2015 | K150103 | Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs Hartalega Sdn Bhd, MY | LZA |
| Dec 18, 2014 | K142588 | Nitrile Powder Free Examination Glove (Blue) Hartalega Sdn Bhd, MY | LZA |
| Sep 12, 2014 | K140050 | NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE Hartalega Sdn Bhd, MY | LZA |
| May 28, 2014 | K133956 | NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN Hartalega Sdn Bhd, MY | LZA |
| May 28, 2014 | K133953 | LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M Hartalega Sdn Bhd, MY | LYY |
| Nov 7, 2013 | K132006 | STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU) Hartalega Sdn Bhd, MY | LZA |
| Jul 5, 2013 | K130473 | NITRILE POWDER FREE EXAMINATION GLOVE (ABLU) Hartalega Sdn Bhd, MY | LZA |
| May 7, 2013 | K123368 | LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT Hartalega Sdn Bhd, MY | LYY |
| Jun 25, 2012 | K120336 | NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U Hartalega Sdn Bhd, MY | LZC |
| Aug 12, 2011 | K110758 | NITRILE POWDER FREE EXAMINATION GLOVES Hartalega Sdn Bhd, MY | LZA |
| Sep 4, 2009 | K091652 | NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS Hartalega Sdn Bhd, MY | LZA |
| Sep 6, 2007 | K071910 | NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK) Hartalega Sdn Bhd, MY | LZA |
| Dec 21, 2006 | K062950 | POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE) Hartalega Sdn Bhd, MY | KGO |
| Nov 17, 2006 | K063046 | NITRILE POWDER FREE EXAMINATION GLOVES (GREEN) Hartalega Sdn Bhd, MY | LZA |
| Jun 14, 2006 | K052583 | BLUE POWDER FREE NITRILE EXAMINATION GLOVES Hartalega Sdn Bhd, MY | LZA |
| Dec 9, 2005 | K052177 | POWDER FREE STERILE LATEX SURGICAL GLOVES Hartalega Sdn Bhd, MY | KGO |
| Aug 12, 2005 | K051777 | NITRILE POWDER FREE EXAMINATION GLOVES (BLUE) Hartalega Sdn Bhd, MY | LZA |
| Jul 26, 2005 | K051778 | NITRILE POWDERED EXAMINATION GLOVES (BLUE) Hartalega Sdn Bhd, MY | LZA |
| Jun 7, 2005 | K050277 | CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW) Hartalega Sdn Bhd, MY | LYY |
| Mar 16, 2005 | K050214 | NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) Hartalega Sdn Bhd, MY | LZA |
| Mar 11, 2005 | K050215 | NITRILE POWDERED EXAMINATION GLOVES (WHITE) Hartalega Sdn Bhd, MY | LZA |
| Jul 9, 2004 | K041391 | FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES Hartalega Sdn Bhd | LZA |
| Nov 18, 2002 | K022671 | FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES Hartalega Sdn Bhd | LZA |
| Nov 29, 2000 | K002593 | POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM Hartalega Sdn Bhd, MY | KGO |
| Jul 26, 2000 | K001959 | POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) Hartalega Sdn Bhd, MY | KGO |
| May 15, 2000 | K993760 | POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS Hartalega Sdn Bhd, MY | LYY |
| Nov 23, 1999 | K993725 | GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS Hartalega Sdn Bhd, MY | LYY |
| Nov 23, 1999 | K993722 | BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS. Hartalega Sdn Bhd, MY | LYY |
| Jul 14, 1999 | K991616 | CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Hartalega Sdn Bhd, MY | LYY |
| Mar 9, 1999 | K990283 | BLUE POWDER-FREE NITRILE EXAMINATION GLOVES Hartalega Sdn Bhd, MY | LZA |
| Mar 13, 1998 | K980572 | POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN) Hartalega Sdn Bhd, MY | LYY |
| Mar 11, 1998 | K980318 | POWDER-FREE LATEX EXAMINATION GLOVES (BLUE) Hartalega Sdn Bhd, MY | LYY |
Newest 50 of 61.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||