The following data is part of a premarket notification filed by Tg Medical Sdn Bhd with the FDA for Powdered Latex Exam Gloves.
| Device ID | K941900 |
| 510k Number | K941900 |
| Device Name: | POWDERED LATEX EXAM GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | TG MEDICAL SDN BHD 24, JALAN RAJA MOKHTAR DUA Kapar, MY 42200 |
| Contact | Lim Wee Chai |
| Correspondent | Lim Wee Chai TG MEDICAL SDN BHD 24, JALAN RAJA MOKHTAR DUA Kapar, MY 42200 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-19 |
| Decision Date | 1994-06-21 |