The following data is part of a premarket notification filed by Terang Nusa Sdn Bhd with the FDA for Patient Examination Gloves (latex).
| Device ID | K891245 |
| 510k Number | K891245 |
| Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | TERANG NUSA SDN BHD LOT 17503, JALAN EMPAT, TAMAN SELAYANG BARU INDUST. ESTATE 68100 Batu Caves Selangor, MY |
| Contact | Guan (mr) |
| Correspondent | Guan (mr) TERANG NUSA SDN BHD LOT 17503, JALAN EMPAT, TAMAN SELAYANG BARU INDUST. ESTATE 68100 Batu Caves Selangor, MY |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-08 |
| Decision Date | 1989-03-22 |