The following data is part of a premarket notification filed by Supermax Sdn Bhd with the FDA for Patient Examination Gloves (latex).
| Device ID | K892287 |
| 510k Number | K892287 |
| Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | SUPERMAX SDN BHD NO. 8, LRG SS 13/3E, SUBANG JAYA INDUSTRIAL EST., 47500 Petaling Jaya, Selangor, MY |
| Contact | Stanley Thai |
| Correspondent | Stanley Thai SUPERMAX SDN BHD NO. 8, LRG SS 13/3E, SUBANG JAYA INDUSTRIAL EST., 47500 Petaling Jaya, 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 | 1989-04-06 |
| Decision Date | 1990-01-10 |