The following data is part of a premarket notification filed by Arista Latindo Industrial, Ltd. P.t. with the FDA for Nitrile Examination Gloves, Powder Free, Polymer Coated, Purple Color.
| Device ID | K030245 |
| 510k Number | K030245 |
| Device Name: | NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE COLOR |
| Classification | Polymer Patient Examination Glove |
| Applicant | ARISTA LATINDO INDUSTRIAL, LTD. P.T. 128 JALAN KYAI HAJI MUHAMMAD MANSYUR Jakarta Barat, ID 11210 |
| Contact | Linga Sumarta |
| Correspondent | Linga Sumarta ARISTA LATINDO INDUSTRIAL, LTD. P.T. 128 JALAN KYAI HAJI MUHAMMAD MANSYUR Jakarta Barat, ID 11210 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-24 |
| Decision Date | 2003-04-04 |