The following data is part of a premarket notification filed by Masif Healthcare Products Sdn. Bhd. with the FDA for Disposable Latex Examination Gloves.
| Device ID | K893767 |
| 510k Number | K893767 |
| Device Name: | DISPOSABLE LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | MASIF HEALTHCARE PRODUCTS SDN. BHD. WISMA TAIKO, NO. 1, JALAN S.P. SEENIVASAGAM IPOH, PERAK, MY 30000 |
| Contact | SEE KHEK |
| Correspondent | SEE KHEK MASIF HEALTHCARE PRODUCTS SDN. BHD. WISMA TAIKO, NO. 1, JALAN S.P. SEENIVASAGAM IPOH, PERAK, MY 30000 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-19 |
| Decision Date | 1989-09-19 |