The following data is part of a premarket notification filed by Seal Polymer Industries Bhd. with the FDA for Patient Examination Gloves.
| Device ID | K921376 |
| 510k Number | K921376 |
| 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 | K. Y Cheah |
| Correspondent | K. Y Cheah 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 | 1992-03-20 |
| Decision Date | 1992-06-15 |