The following data is part of a premarket notification filed by Pamitex Industries Sdn Bhd with the FDA for Health-plus, Sanitex, Reliance Pre-powdered Laxtex Examination Glove.
| Device ID | K000828 |
| 510k Number | K000828 |
| Device Name: | HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | PAMITEX INDUSTRIES SDN BHD 2 1/2 MILES, JALAN RASAH SEREMBAN, NAGERI SEMBILAN Darul Khusus, MY 70300 |
| Contact | Said Awang |
| Correspondent | Said Awang PAMITEX INDUSTRIES SDN BHD 2 1/2 MILES, JALAN RASAH SEREMBAN, NAGERI SEMBILAN Darul Khusus, MY 70300 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-14 |
| Decision Date | 2000-04-07 |