The following data is part of a premarket notification filed by Pt. Sarana Indoprotex with the FDA for Andal.
| Device ID | K950823 |
| 510k Number | K950823 |
| Device Name: | ANDAL |
| Classification | Latex Patient Examination Glove |
| Applicant | PT. SARANA INDOPROTEX I.R. SUTAMI KM 07 BANDAR LAMPUNG 35001 Indonesia, ID |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-23 |
| Decision Date | 1995-05-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ANDAL 87594130 not registered Dead/Abandoned |
Chang, Andrew 2017-09-01 |
![]() ANDAL 74149418 not registered Dead/Abandoned |
PT. SARANA INDOPROTEX 1991-03-19 |
![]() ANDAL 73379855 1259442 Dead/Cancelled |
General Refractories Company 1982-08-13 |