The following data is part of a premarket notification filed by Arista Latindo Industrial, Ltd. P.t. with the FDA for Latex Examination Gloves.
| Device ID | K943707 |
| 510k Number | K943707 |
| Device Name: | LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | ARISTA LATINDO INDUSTRIAL, LTD. P.T. JL: K.H.MOH MANSYUR NO. 128 Jakarta, ID 11210 |
| Contact | Gentho Sumarta |
| Correspondent | Gentho Sumarta ARISTA LATINDO INDUSTRIAL, LTD. P.T. JL: K.H.MOH MANSYUR NO. 128 Jakarta, ID 11210 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-01 |
| Decision Date | 1994-11-30 |