The following data is part of a premarket notification filed by Seal Polymer Industries Bhd. with the FDA for Patient Examination Gloves.
| Device ID | K915607 |
| 510k Number | K915607 |
| Device Name: | PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | SEAL POLYMER INDUSTRIES BHD. NO. 28-B JALAN SS15/8 SUUBANG JAYA, 47500 PETALING Jaya Selangor W. Malaysia, MY |
| Contact | Mui Fah |
| Correspondent | Mui Fah SEAL POLYMER INDUSTRIES BHD. NO. 28-B JALAN SS15/8 SUUBANG JAYA, 47500 PETALING Jaya Selangor W. 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 | 1991-12-16 |
| Decision Date | 1993-03-04 |