This company has registrations in United States, Brazil, Saudi Arabia, Canada, Russia — 5 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 | K231446 | Single-Use Latex Sterile Surgical Gloves (SG100) | 2023-09-22 |
| US | K221747 | Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs | 2022-12-01 |
| US | K222693 | Single-use medical latex examination gloves (LG100) | 2022-09-24 |
| BR | 80660079063 | LUVA DE LÁTEX CIRÚRGICA SEM PÓ ZELARA | Class II |
| BR | 80660070069 | Protetor de Sonda Zelara | Class I |
| BR | 80722800024 | Protetor de Sonda para Ultrassom MedPex | Class I |
| SA | ME0000020086SFDAA00001 | Disposable Medical latex Examination Glove | — |