This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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 | K223903 | Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105) | 2023-01-27 |
| US | K183441 | Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs | 2019-10-04 |
| US | K171378 | Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs | 2017-09-14 |
| BR | 80605410008 | LUVA PARA PROCEDIMENTO NÃO CIRÚRGICO - EM LÁTEX - COM PÓ - TALGE | Class I |
| BR | 80808480016 | Luvas para procedimentos não cirúrgicos bcp300 | Class I |
| SA | ME0000001406SFDAA00001 | Sempercare Vinyl | — |
| SA | ME0000001406SFDAA00002 | Sempercare Edition | — |