The following data is part of a premarket notification filed by Pt. Smart Glove Indonesia with the FDA for Polymer Coated, Powder Free Latex Examination Glove (white).
| Device ID | K040792 |
| 510k Number | K040792 |
| Device Name: | POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE) |
| Classification | Latex Patient Examination Glove |
| Applicant | PT. SMART GLOVE INDONESIA KAWASAN INDUSTRI MEDAN STAR J1 RAYA MEDAN-LUBUK PAKAM KM.19 Tg Morawa-deli Serdang Utara, ID 20362 |
| Contact | Foo Khon Pu |
| Correspondent | Foo Khon Pu PT. SMART GLOVE INDONESIA KAWASAN INDUSTRI MEDAN STAR J1 RAYA MEDAN-LUBUK PAKAM KM.19 Tg Morawa-deli Serdang Utara, ID 20362 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-29 |
| Decision Date | 2004-08-12 |