Data / Medical devices / Malaysia / Hartalega NGC Sdn. Bhd. (lot 39496)
Hartalega NGC Sdn. Bhd. (lot 39496): FDA-registered device maker in Sepang Selangor, Malaysia, 83 510(k) clearances
Hartalega NGC Sdn. Bhd. (lot 39496) is registered with the FDA (registration 3019769825) in Sepang Selangor, Malaysia. It lists 7 device types. The FDA files 83 510(k) clearances under its listings, the newest dated January 8, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3019769825
- Address
- No.2 (Lot 39496), Persiaran Tanjung Kawasan Perindustrian Tanjung, Jalan B20, Sepang Selangor, Malaysia, 43900
- Owner or operator
- Hartalega NGC Sdn. Bhd. (Lot 39496) (10090827)
- Roles
- Manufacturer
- First device listed
- May 20, 2024
- 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), Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue), BiodegradableNitrilePowderFreeExaminationGlove TestedforUsewith Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour), CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW), CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Manufacturer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer | accessdata.fda.gov |
| Powder-Free Polychloroprene Patient Examination Glove | OPC | 1 | Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| January 8, 2025 | K243818 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| May 17, 2023 | K223437 | Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| November 11, 2022 | K222225 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| September 24, 2022 | K221718 | Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) | KGO | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| May 26, 2022 | K214074 | Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs | KGO | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| August 3, 2021 | K211758 | Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) | OPC | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| 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 25, 2020 | K201772 | Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | LZA | Substantially Equivalent | Hartalega NGC 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 |
| August 5, 2020 | K201530 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey) | LZA | Substantially Equivalent | Hartalega NGC 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 |
| April 25, 2020 | K200581 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| April 6, 2020 | K200019 | Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| November 8, 2019 | K192232 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| September 26, 2019 | K190454 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended Cuff | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| August 16, 2019 | K183536 | Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove | KGO | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| June 28, 2019 | K183389 | Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove | KGO | Substantially Equivalent | Hartalega NGC 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 |
| November 6, 2017 | K172442 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) | LZA | Substantially Equivalent | Hartalega NGC 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 |
| June 30, 2017 | K170794 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| May 5, 2017 | K170152 | POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN) | KGO | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| March 3, 2017 | K162646 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) | LZA | Substantially Equivalent | Hartalega NGC 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 |
| February 6, 2017 | K162923 | NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK VIOLET BLUE | LZA | Substantially Equivalent | Hartalega NGC 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 |
| March 31, 2016 | K151997 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| October 21, 2015 | K151836 | NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| September 18, 2015 | K151684 | Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| August 24, 2015 | K151343 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange) | LZA | Substantially Equivalent | Hartalega NGC 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 | K150110 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Blue (DKBU), Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dark Violet Blue (DVBU) | LZA | Substantially Equivalent | Hartalega NGC 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 |
| March 6, 2015 | K143419 | Patient Examination Gloves | LYY | Substantially Equivalent | Hartalega NGC 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 |
| 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 |
| July 24, 2014 | K140890 | NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU) | LZA | Substantially Equivalent | Hartalega NGC Sdn. Bhd. | accessdata.fda.gov |
| June 20, 2014 | K140610 | NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU) | LZA | Substantially Equivalent | Hartalega NGC 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 |
| 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 |
| 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 |
| 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 Medical Glove, Specialty
- All makers of Latex Patient Examination Glove
- All makers of Surgeon'S Gloves
- All makers of Powder-Free Polychloroprene Patient Examination Glove
- All makers of Fentanyl And Other Opioid Protection Glove
Updated January 8, 2025. 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.