The following data is part of a premarket notification filed by Supermax Sdn Bhd with the FDA for Patient Examination Latex Gloves, Hypoallergenic.
| Device ID | K915251 |
| 510k Number | K915251 |
| Device Name: | PATIENT EXAMINATION LATEX GLOVES, HYPOALLERGENIC |
| Classification | Latex Patient Examination Glove |
| Applicant | SUPERMAX SDN BHD 27A JALAN SS 19/6C,SUBANG JAYA 47500 PETALING JAYA Selangor, Malaysia, MG |
| Contact | Stanley Thai |
| Correspondent | Stanley Thai SUPERMAX SDN BHD 27A JALAN SS 19/6C,SUBANG JAYA 47500 PETALING JAYA Selangor, Malaysia, MG |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-13 |
| Decision Date | 1993-01-22 |