The following data is part of a premarket notification filed by Arista Latindo Industrial, Ltd. P.t. with the FDA for Strawberry Scented Latex Examination Gloves.
| Device ID | K896135 |
| 510k Number | K896135 |
| Device Name: | STRAWBERRY SCENTED LATEX EXAMINATION 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 | 1989-10-19 |
| Decision Date | 1989-12-01 |