The following data is part of a premarket notification filed by Masif Healthcare Products Sdn. Bhd. with the FDA for Latex Examination Glove.
| Device ID | K945490 |
| 510k Number | K945490 |
| Device Name: | LATEX EXAMINATION GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | MASIF HEALTHCARE PRODUCTS SDN. BHD. 1, JALAN S.P. SEENIVASAGAM 3000 IPOH, PERAK MALAYSIA, MY 3000 IPOH |
| Contact | KOW P ONG |
| Correspondent | KOW P ONG MASIF HEALTHCARE PRODUCTS SDN. BHD. 1, JALAN S.P. SEENIVASAGAM 3000 IPOH, PERAK MALAYSIA, MY 3000 IPOH |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-08 |
| Decision Date | 1994-12-08 |