The following data is part of a premarket notification filed by Sin Super Holdings Sdn Bhd with the FDA for Patient Examination Gloves (latex).
| Device ID | K891223 |
| 510k Number | K891223 |
| Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | SIN SUPER HOLDINGS SDN BHD LOT 1185 KAMUNTING INDUSTRIAL ESTATE 34600 Kamunting, Perak, MY |
| Contact | Bok Tek |
| Correspondent | Bok Tek SIN SUPER HOLDINGS SDN BHD LOT 1185 KAMUNTING INDUSTRIAL ESTATE 34600 Kamunting, Perak, MY |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-07 |
| Decision Date | 1989-04-26 |