The following data is part of a premarket notification filed by Arista Latindo Industrial Ltd. P.t with the FDA for Non-sterile Latex Examination Gloves(pre-powdered).
| Device ID | K925683 |
| 510k Number | K925683 |
| Device Name: | NON-STERILE LATEX EXAMINATION GLOVES(PRE-POWDERED) |
| 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 | 1992-11-03 |
| Decision Date | 1993-06-04 |