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 |