The following data is part of a premarket notification filed by Arista Latindo Industrial Ltd. P.t with the FDA for Powderfree Natural Latex Gloves.
| Device ID | K921389 |
| 510k Number | K921389 |
| Device Name: | POWDERFREE NATURAL LATEX GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | ARISTA LATINDO INDUSTRIAL LTD. P.T P.O. BOX 1129 JAKARTA Indonesia, ID |
| Contact | Gentho Sumarta |
| Correspondent | Gentho Sumarta ARISTA LATINDO INDUSTRIAL LTD. P.T P.O. BOX 1129 JAKARTA 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 | 1992-03-23 |
| Decision Date | 1993-08-05 |