The following data is part of a premarket notification filed by Pt. Smartglove Indonesia with the FDA for Powder Free Nitrile Examination Gloves (natural, Blue,purple).
| Device ID | K030284 |
| 510k Number | K030284 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE) |
| Classification | Polymer Patient Examination Glove |
| Applicant | PT. SMARTGLOVE INDONESIA STAR JL.RAYA MEDAN-LUBUK PAKAM KM.19, TG.MAROWA B-TG.MAROWA Deli Serdang,sumatera Utara, ID 20362 |
| Contact | Foo Khon Pu |
| Correspondent | Foo Khon Pu PT. SMARTGLOVE INDONESIA STAR JL.RAYA MEDAN-LUBUK PAKAM KM.19, TG.MAROWA B-TG.MAROWA Deli Serdang,sumatera Utara, 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 | 2003-01-27 |
| Decision Date | 2003-03-25 |