The following data is part of a premarket notification filed by Kilang Barangan Getah Dioh with the FDA for Powdered Latex Examination Gloves, Non-sterile.
| Device ID | K984125 |
| 510k Number | K984125 |
| Device Name: | POWDERED LATEX EXAMINATION GLOVES, NON-STERILE |
| Classification | Latex Patient Examination Glove |
| Applicant | KILANG BARANGAN GETAH DIOH LOT 9, KAWASAN PERINDUSTRIAN DIOH, KUALA PILAH Negeri Sembilan, MY 72000 |
| Contact | Norli Manaff |
| Correspondent | Norli Manaff KILANG BARANGAN GETAH DIOH LOT 9, KAWASAN PERINDUSTRIAN DIOH, KUALA PILAH Negeri Sembilan, MY 72000 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-18 |
| Decision Date | 1999-02-09 |