The following data is part of a premarket notification filed by Pt. Smart Glove Indonesia with the FDA for Polymer Coat Powder Free Nitrile Examination Gloves, Green And White Color.
| Device ID | K041848 |
| 510k Number | K041848 |
| Device Name: | POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR |
| Classification | Polymer Patient Examination Glove |
| Applicant | PT. SMART GLOVE INDONESIA KAWASAN INDUSTRI MEDAN STAR JL RAYA MEDAN-LUBUK PAKAM KM.19 Tg Morawa-deli Serdang, ID 20362 |
| Contact | Foo Khon Pu |
| Correspondent | Foo Khon Pu PT. SMART GLOVE INDONESIA KAWASAN INDUSTRI MEDAN STAR JL RAYA MEDAN-LUBUK PAKAM KM.19 Tg Morawa-deli Serdang, ID 20362 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-08 |
| Decision Date | 2004-08-20 |