Data / Medical devices / Malaysia / Latexx Manufacturing Sdn. Bhd.
Latexx Manufacturing Sdn. Bhd.: FDA-registered device maker in TAIPING Perak, Malaysia, 23 510(k) clearances
Latexx Manufacturing Sdn. Bhd. is registered with the FDA (registration 8041003) in TAIPING Perak, Malaysia. It lists 6 device types. The FDA files 23 510(k) clearances under its listings, the newest dated January 27, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8041003
- FEI number
- 3009157666
- Address
- Lot 18374, Jalan Perusahaan 3 Kamunting Industrial Estate, TAIPING Perak, Malaysia, 34600
- Owner or operator
- Latexx Manufacturing Sdn. Bhd. (8041003)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 7, 2007
- Registered through
- 2026
- Brand names listed
- Black Colour Powder-Free Nitrile Rubber Examination Gloves, Latex Examination Gloves, Latex Examination Powder-Free Gloves, Latex patient examination glove, Latexx Manufacturing Non-Chlorinated, Polymer Coated, Powder Free Natural Rubber, Medtexx Blue Colour Powder-Free Nitrile Rubber Examination Gloves, Nitrile Cornflower Blue Powder-Free Exam Tested for Use with Chemotherapy Drugs (Non-Sterile), Nitrile Exam 200 NBR PF VB 200pc (IMCO) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer, 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 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Contract manufacturer, 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 27, 2023 | K223903 | Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105) | LZA | Substantially Equivalent | Semperit Investments Asia Pte , Ltd. | accessdata.fda.gov |
| October 4, 2019 | K183441 | Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | Semperit Investments Asia Pte , Ltd. | accessdata.fda.gov |
| September 14, 2017 | K171378 | Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs | LZA | Substantially Equivalent | Semperit Investments Asia Pte , Ltd. | accessdata.fda.gov |
| June 29, 2012 | K120963 | POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Medtexx Manufacturing Sdn. Bhd. | accessdata.fda.gov |
| March 14, 2012 | K102189 | POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM | LZC | Substantially Equivalent | Latexx Manufacturing Sdn.Bhd. | accessdata.fda.gov |
| April 15, 2011 | K110921 | NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| July 14, 2008 | K081089 | KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM | LZC | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| July 9, 2008 | K081260 | KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES | LZA | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| October 4, 2007 | K071740 | CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES | LZA | Substantially Equivalent | Medtexx Manufacturing Sdn. Bhd. | accessdata.fda.gov |
| May 10, 2007 | K070821 | POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE | LYY | Substantially Equivalent | Medtexx Manufacturing Sdn. Bhd. | accessdata.fda.gov |
| March 15, 2007 | K070072 | NON-CHLORINATED POLYMER COATED POWDER-FREE NATURAL LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Medtexx Manufacturing Sdn. Bhd. | accessdata.fda.gov |
| August 3, 2005 | K051378 | POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | LZA | Substantially Equivalent | Medline | accessdata.fda.gov |
| March 15, 2004 | K034052 | BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES | LZA | Substantially Equivalent | Latexx Manufacturing Sdn.Bhd. | accessdata.fda.gov |
| November 13, 2003 | K032444 | NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY | LZC | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| October 11, 2002 | K022765 | NITRILE POWDER-FREE EXAMINATION GLOVES | LZA | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
| August 15, 2002 | K022548 | MEDTEXX BLUE COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES | LZA | Substantially Equivalent | Latexx Manufacturing Sdn.Bhd. | accessdata.fda.gov |
| March 4, 2002 | K014087 | LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FREE RUBBER LATEX EXAMINATION GLOVE | LYY | Substantially Equivalent | Latexx Manufacturing Sdn.Bhd. | accessdata.fda.gov |
| January 16, 2002 | K013560 | SEMPERMED SUPREME, SIZES 5.5, 6, 6.5, 7, 7.5, 8, 8.5, AND 9 | KGO | Substantially Equivalent | Semperit Technische Produkte Gesellshaft | accessdata.fda.gov |
| November 16, 2001 | K012819 | SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9 | KGO | Substantially Equivalent | Semperit Technische Produkte Gesellshaft | accessdata.fda.gov |
| August 22, 2001 | K011749 | LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS | LYY | Substantially Equivalent | Sempermed USA, Inc. | accessdata.fda.gov |
| June 11, 1998 | K981767 | QTEXX POWDERFREE LATEX EXAMINATION GLOVES | LYY | Substantially Equivalent | Latexx Partners Bhd. | accessdata.fda.gov |
| June 1, 1998 | K981159 | PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | Latexx Partners Bhd. | accessdata.fda.gov |
| April 26, 1989 | K891223 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | Substantially Equivalent | Sin Super Holdings Sdn Bhd | accessdata.fda.gov |
Compare with other makers
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Glove, Specialty
- All makers of Polymer Patient Examination Glove
- All makers of Latex Patient Examination Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Surgeon'S Gloves
Updated January 27, 2023. 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.