Data / Medical devices / Sri Lanka / Ansell Lanka (pvt.), Ltd.
Ansell Lanka (pvt.), Ltd.: FDA-registered device maker in BIYAGAMA Gampaha, Sri Lanka, 15 510(k) clearances
Ansell Lanka (pvt.), Ltd. is registered with the FDA (registration 8041180) in BIYAGAMA Gampaha, Sri Lanka. It lists 4 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
- 8041180
- FEI number
- 3002806389
- Address
- Biyagama Export Processing Zone, BIYAGAMA Gampaha, Sri Lanka, --
- Owner or operator
- ANSELL HEALTHCARE PRODUCTS LLC (8020065)
- Roles
- Manufacturer
- First device listed
- November 21, 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 |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 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 |
| 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 |
| October 28, 2016 | K160974 | Gammex Cut-Resistant Glove Liner | 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 |
| 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 |
| January 31, 2000 | K993857 | THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (60 MICROGRAMS OR | KGO | Substantially Equivalent | Ansell Perry | accessdata.fda.gov |
| October 29, 1999 | K992953 | SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PROTEIN LABEL CLAIM | 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 |
| January 28, 1991 | K904769 | SENSITOUCH | KGO | Substantially Equivalent | Ansell Intl. | accessdata.fda.gov |
Compare with other makers
- All makers of Surgeon'S Gloves
- All makers of Medical Glove, Specialty
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Accessory, Surgical Apparel
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.