The following data is part of a premarket notification filed by Agrimal Industries Sdn. Bhd. with the FDA for Patient Latex Examination Gloves.
| Device ID | K894758 |
| 510k Number | K894758 |
| Device Name: | PATIENT LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | AGRIMAL INDUSTRIES SDN. BHD. NO. 3, JALAN SONGKIT SEBELAS TAMAN SENTOSA, 80150 JOHOR Bahru, Johor, Malaysia, MY |
| Contact | Chee Seng |
| Correspondent | Chee Seng AGRIMAL INDUSTRIES SDN. BHD. NO. 3, JALAN SONGKIT SEBELAS TAMAN SENTOSA, 80150 JOHOR Bahru, Johor, Malaysia, MY |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-26 |
| Decision Date | 1989-09-26 |