Data / Medical devices / Malaysia / Hartalega Sdn Bhd
Hartalega Sdn Bhd: FDA-registered device maker in Bestari Jaya Selangor, Malaysia, 62 510(k) clearances
Hartalega Sdn Bhd is registered with the FDA (registration 8040614) in Bestari Jaya Selangor, Malaysia. It lists 5 device types. The FDA files 62 510(k) clearances under its listings, the newest dated October 2, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8040614
- FEI number
- 3002807146
- Address
- No 7, Kawasan Perusahaan Suria, Bestari Jaya Selangor, Malaysia, 45600
- Owner or operator
- HARTALEGA SDN BHD (8040614)
- Roles
- Specification developer
- First device listed
- November 29, 2007
- Registered through
- 2026
- Brand names listed
- BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS., BLUE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE POWDER-FREE NITRILE EXAMINATION GLOVES, Biodegradable Nitrile Powder Free Examination Glove (Blue), Blue Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs - CBLU, CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW), Chlorinated Powder Free Latex Examination Glove with Protein Content Labeling Claim (50 micrograms or less), Confiderm 3 14-6N3x and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Specification developer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Specification developer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Specification developer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Specification developer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| October 2, 2020 | 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 | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| August 5, 2020 | K201531 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| June 1, 2020 | K200897 | Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) | KGO | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| November 16, 2018 | K180645 | Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green) | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| November 2, 2018 | 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 | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| August 17, 2018 | K173509 | Biodegradable Nitrile Powder Free Examination Glove (Blue) | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| August 10, 2018 | K180644 | Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| June 14, 2018 | K180505 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White) | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| December 12, 2017 | K173137 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| October 12, 2017 | K171874 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue) | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| May 5, 2017 | K170152 | POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN) | KGO | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| February 8, 2017 | K162491 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| January 24, 2017 | K162924 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU) | LZA | Substantially Equivalent | Hartalega Sdb. Bhd. | accessdata.fda.gov |
| January 9, 2017 | K162819 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| January 9, 2017 | K162818 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| December 20, 2016 | K160928 | Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green) | KGO | Substantially Equivalent | Hartalega Sdb. Bhd. | accessdata.fda.gov |
| October 13, 2016 | K160562 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Hartalega Snd. Bhd. | accessdata.fda.gov |
| August 4, 2016 | K161006 | Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove | LYY | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| August 4, 2016 | K160560 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| July 28, 2016 | K161008 | POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE | KGO | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| June 9, 2015 | K150593 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| April 23, 2015 | K150103 | Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| December 18, 2014 | K142805 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU) | LZA | Substantially Equivalent | Hartalega Sdb. Bhd. | accessdata.fda.gov |
| December 18, 2014 | K142588 | Nitrile Powder Free Examination Glove (Blue) | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| November 25, 2014 | K142270 | LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE | LYY | Substantially Equivalent | Hartalega Sdb. Bhd. | accessdata.fda.gov |
| September 12, 2014 | K140050 | NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| May 28, 2014 | K133956 | NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| May 28, 2014 | K133953 | LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M | LYY | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| November 7, 2013 | K132006 | STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU) | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| July 5, 2013 | K130473 | NITRILE POWDER FREE EXAMINATION GLOVE (ABLU) | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| May 7, 2013 | K123368 | LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT | LYY | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| June 25, 2012 | K120336 | NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U | LZC | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| February 2, 2012 | K112976 | NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM | LZA | Substantially Equivalent | Hartalega Snd. Bhd. | accessdata.fda.gov |
| August 12, 2011 | K110758 | NITRILE POWDER FREE EXAMINATION GLOVES | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| September 4, 2009 | K091652 | NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| September 6, 2007 | K071910 | NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK) | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| November 17, 2006 | K063046 | NITRILE POWDER FREE EXAMINATION GLOVES (GREEN) | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| June 14, 2006 | K052583 | BLUE POWDER FREE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| December 9, 2005 | K052177 | POWDER FREE STERILE LATEX SURGICAL GLOVES | KGO | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| August 12, 2005 | K051777 | NITRILE POWDER FREE EXAMINATION GLOVES (BLUE) | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| July 26, 2005 | K051778 | NITRILE POWDERED EXAMINATION GLOVES (BLUE) | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| June 7, 2005 | K050277 | CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW) | LYY | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| March 16, 2005 | K050214 | NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| March 11, 2005 | K050215 | NITRILE POWDERED EXAMINATION GLOVES (WHITE) | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| November 29, 2000 | K002593 | POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM | KGO | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| July 26, 2000 | K001959 | POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) | KGO | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| May 15, 2000 | K993760 | POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS | LYY | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| November 23, 1999 | K993725 | GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS | LYY | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| November 23, 1999 | K993722 | BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS. | LYY | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| July 14, 1999 | K991616 | CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| March 9, 1999 | K990283 | BLUE POWDER-FREE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| March 13, 1998 | K980572 | POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN) | LYY | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| March 11, 1998 | K980318 | POWDER-FREE LATEX EXAMINATION GLOVES (BLUE) | LYY | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| December 11, 1997 | K973871 | LOW POWDER POLYMER LATEX EXAMINATION GLOVES (WITH PROTEIN LABELING CLAIM) | LYY | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| December 11, 1997 | K973778 | POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| February 10, 1997 | K963804 | PATIENT EXAMINATION GLOVES : NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| February 7, 1997 | K964148 | PATIENT EXAMINATION GLOVES; CHLORINATED POWDERFREE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| October 11, 1996 | K954416 | POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| May 3, 1996 | K954221 | POLYMER COATED CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| March 12, 1996 | K954415 | PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM | LYY | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| March 23, 1995 | K945885 | PATIENT EXAMINATION GLOVES | LYY | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| May 31, 1989 | K892104 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Latex Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Surgeon'S Gloves
- All makers of Fentanyl And Other Opioid Protection Glove
Updated October 2, 2020. 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.