The following data is part of a premarket notification filed by Malaytex Usa, Inc. with the FDA for Hypoallergenic Cranberry/malaytex Latex Exam Glove.
| Device ID | K904526 |
| 510k Number | K904526 |
| Device Name: | HYPOALLERGENIC CRANBERRY/MALAYTEX LATEX EXAM GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | MALAYTEX USA, INC. 1524 KEARNEY ST. El Cerrito, CA 94530 |
| Contact | P. S Hew |
| Correspondent | P. S Hew MALAYTEX USA, INC. 1524 KEARNEY ST. El Cerrito, CA 94530 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-01 |
| Decision Date | 1990-11-23 |