Data / Medical devices / Malaysia / Ansell N.P. Sdn. Bhd.
Ansell N.P. Sdn. Bhd.: FDA-registered device maker in Melaka, Malaysia, 15 510(k) clearances
Ansell N.P. Sdn. Bhd. is registered with the FDA (registration 8043736) in Melaka, Malaysia. It lists 5 device types. The FDA files 15 510(k) clearances under its listings, the newest dated October 20, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8043736
- FEI number
- 3003221560
- Address
- Lot 80, Air Keroh Ind. Estate, Melaka, Malaysia, 75450
- Owner or operator
- ANSELL HEALTHCARE PRODUCTS LLC (8020065)
- Roles
- Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- November 28, 2007
- Registered through
- 2026
- Brand names listed
- GAMMEX PI PLUS GLOVE-IN-GLOVE SYSTEM TESTED FOR USE WITH CHEMOTHERAPY DRUGS, PI Hybrid Micro
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
| Radiographic Protective Glove | IWP | 1 | Exporter to the US, Manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| October 20, 2023 | K231902 | GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090) | KGO | Substantially Equivalent | Ansell Healthcare | accessdata.fda.gov |
| May 26, 2023 | K213289 | Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| May 23, 2019 | K190018 | Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| March 22, 2019 | K182948 | Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| February 6, 2018 | K171375 | Gammex PI Breach Detect Powder Free Surgical Glove | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| March 9, 2016 | K151694 | Gammex PI Hybrid Surgical Gloves | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| September 2, 2011 | K111139 | DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES, TESTED FOR U | KGO | Substantially Equivalent | Ansell Healthcare Products, Inc. | accessdata.fda.gov |
| July 7, 2011 | K103714 | ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| December 13, 2007 | K071746 | DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| August 17, 2005 | K051793 | ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE) | KGO | Substantially Equivalent | Ansell Healthcare Products, LLC | accessdata.fda.gov |
| February 16, 2000 | K000295 | ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | KGO | Substantially Equivalent | Ansell Perry | accessdata.fda.gov |
| February 26, 1999 | K984558 | DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) | KGO | Substantially Equivalent | Ansell Perry | accessdata.fda.gov |
| December 14, 1998 | K983489 | ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE) | KGO | Substantially Equivalent | Ansell Perry | accessdata.fda.gov |
| November 30, 1998 | K982453 | NON-STERILE E.P. LATEX EXAMINATION GLOVE | LYY | Substantially Equivalent | Ansell Perry | accessdata.fda.gov |
| June 26, 1985 | K850635 | ANSELL NO POWDER SURGEON'S GLOVES | KGO | Substantially Equivalent | Ansell, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Surgeon'S Gloves
- All makers of Radiographic Protective Glove
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Medical Glove, Specialty
- All makers of Latex Patient Examination Glove
Updated October 20, 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.