The following data is part of a premarket notification filed by Koon Seng Sdn.bhd with the FDA for Patient Examination Gloves (latex).
| Device ID | K891821 |
| 510k Number | K891821 |
| Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | KOON SENG SDN.BHD PLO. 89, JALAN TEMBAGA DUA PASIR GUDANG INDUSTRIAL ESTATE 81707 Pasir Gudan, Johor, MY |
| Contact | Lee Chuan |
| Correspondent | Lee Chuan KOON SENG SDN.BHD PLO. 89, JALAN TEMBAGA DUA PASIR GUDANG INDUSTRIAL ESTATE 81707 Pasir Gudan, Johor, MY |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-24 |
| Decision Date | 1989-05-31 |