This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | 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) | 2023-10-20 |
| US | K230079 | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential | 2023-08-23 |
| US | K213289 | Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs | 2023-05-26 |
| BR | 81496190014 | LUVA PARA PROCEDIMENTOS NÃO-CIRÚRGICOS E CONTRA AGENTES QUÍMICOS Supre | Class I |
| BR | 81496190015 | LUVA PARA PROCEDIMENTOS NÃO-CIRÚRGICOS E CONTRA AGENTES QUÍMICOS Lifes | Class I |
| BR | 81496199001 | Encore Latex Textured | Class II |
| CA | 6747 | CONTEMPO POWER PLAY EXTRA STRENGTH WITH SPERMICIDE LUBRICATED LATEX CONDOMS | Class II |
| CA | 327 | SENSI-TOUCH LATEX DISPOSABLE POWDER-FREE EXAMINATION GLOVES | Class II |
| CA | 3420 | NITRA-TOUCH POWDER-FREE NITRILE NON-STERILE EXAM GLOVE | Class II |