Hartalega Sdn Bhd
Bestari Jaya Selangor, MY
HARTALEGA SDN BHD appears in FDA device records in Bestari Jaya Selangor, MY. FDA records list 61 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 61FDA records hold 61 510(k) clearances for Hartalega Sdn Bhd between 1989 and 2020. The busiest year on record is 2005, with 6. The most recent is 2020, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1994 | 2 |
| 1995 | 1 |
| 1996 | 3 |
| 1997 | 4 |
| 1998 | 2 |
| 1999 | 4 |
| 2000 | 3 |
| 2002 | 1 |
| 2004 | 1 |
| 2005 | 6 |
| 2006 | 3 |
| 2007 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 3 |
| 2014 | 4 |
| 2015 | 2 |
| 2016 | 3 |
| 2017 | 6 |
| 2018 | 5 |
| 2020 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | |
| K201531 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | LZA | Substantially Equivalent | |
| 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 | |
| K180645 | Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green) | LZA | Substantially Equivalent | |
| 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 | |
| K173509 | Biodegradable Nitrile Powder Free Examination Glove (Blue) | LZA | Substantially Equivalent | |
| K180644 | Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green | LZA | Substantially Equivalent | |
| 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 | |
| K173137 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) | LZA | Substantially Equivalent | |
| K171874 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue) | LZA | Substantially Equivalent | |
| K170152 | POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN) | KGO | Substantially Equivalent | |
| K162491 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) | LZA | Substantially Equivalent | |
| K162819 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | |
| K162818 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) | LZA | Substantially Equivalent | |
| K161006 | Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove | LYY | Substantially Equivalent | |
| K160560 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) | LZA | Substantially Equivalent | |
| K161008 | POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE | KGO | Substantially Equivalent | |
| K150593 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) | LZA | Substantially Equivalent | |
| K150103 | Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs | LZA | Substantially Equivalent | |
| K142588 | Nitrile Powder Free Examination Glove (Blue) | LZA | Substantially Equivalent | |
| K140050 | NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE | LZA | Substantially Equivalent | |
| K133956 | NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN | LZA | Substantially Equivalent | |
| K133953 | LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M | LYY | Substantially Equivalent | |
| K132006 | STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU) | LZA | Substantially Equivalent | |
| K130473 | NITRILE POWDER FREE EXAMINATION GLOVE (ABLU) | LZA | Substantially Equivalent | |
| K123368 | LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT | LYY | Substantially Equivalent | |
| K120336 | NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U | LZC | Substantially Equivalent | |
| K110758 | NITRILE POWDER FREE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K091652 | NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS | LZA | Substantially Equivalent | |
| K071910 | NITRILE POWDER FREE EXAMINATION GLOVES (BLUE), NITRILE POWDER FREE EXAMINATION GLOVES (PINK) | LZA | Substantially Equivalent | |
| K062950 | POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE) | KGO | Substantially Equivalent | |
| K063046 | NITRILE POWDER FREE EXAMINATION GLOVES (GREEN) | LZA | Substantially Equivalent | |
| K052583 | BLUE POWDER FREE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K052177 | POWDER FREE STERILE LATEX SURGICAL GLOVES | KGO | Substantially Equivalent | |
| K051777 | NITRILE POWDER FREE EXAMINATION GLOVES (BLUE) | LZA | Substantially Equivalent | |
| K051778 | NITRILE POWDERED EXAMINATION GLOVES (BLUE) | LZA | Substantially Equivalent | |
| K050277 | CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW) | LYY | Substantially Equivalent | |
| K050214 | NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) | LZA | Substantially Equivalent | |
| K050215 | NITRILE POWDERED EXAMINATION GLOVES (WHITE) | LZA | Substantially Equivalent | |
| K041391 | FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K022671 | FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K002593 | POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM | KGO | Substantially Equivalent | |
| K001959 | POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) | KGO | Substantially Equivalent | |
| K993760 | POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS | LYY | Substantially Equivalent | |
| K993725 | GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS | LYY | Substantially Equivalent | |
| K993722 | BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS. | LYY | Substantially Equivalent | |
| K991616 | CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | LYY | Substantially Equivalent | |
| K990283 | BLUE POWDER-FREE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K980572 | POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN) | LYY | Substantially Equivalent | |
| K980318 | POWDER-FREE LATEX EXAMINATION GLOVES (BLUE) | LYY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8040614 | 3002807146 | HARTALEGA SDN BHD | No 7, Kawasan Perusahaan Suria, Bestari Jaya Selangor 45600 MY | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain