Data / Medical devices / Malaysia / GP Lumut
GP Lumut: FDA-registered device maker in Sitiawan Perak, Malaysia, 11 510(k) clearances
GP Lumut is registered with the FDA (registration 3011189071) in Sitiawan Perak, Malaysia. It lists 4 device types. The FDA files 11 510(k) clearances under its listings, the newest dated September 27, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011189071
- Address
- Lot No. 15652, Kawasan Perindustrian Kampung Acheh, Sitiawan Perak, Malaysia, 32000
- Owner or operator
- GP Lumut (10047087)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- June 26, 2014
- Registered through
- 2026
- Brand names listed
- Benco dental, Purple 9.5
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 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 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, Manufacturer, 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 |
|---|---|---|---|---|---|---|
| September 27, 2024 | K241909 | Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid | LZA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| June 27, 2018 | K180646 | Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs | LZC | Substantially Equivalent | Halyard Health | accessdata.fda.gov |
| August 25, 2017 | K171104 | Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue) | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| March 9, 2012 | K113423 | KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE | LZA | Substantially Equivalent | Kimberly-Clark Corp. | 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 21, 2010 | K101596 | KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER- | LZC | Substantially Equivalent | Kimberly-Clark | 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 |
| November 18, 2005 | K052502 | NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES | LZA | Substantially Equivalent | Yty Industry (Manjung) Sdn Bhd | accessdata.fda.gov |
| July 25, 2003 | K031580 | NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent | Green Prospect Sdn Bhd | accessdata.fda.gov |
| October 11, 2002 | K022765 | NITRILE POWDER-FREE EXAMINATION GLOVES | LZA | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Glove, Specialty
Updated September 27, 2024. 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.