The following data is part of a premarket notification filed by Pt. Smart Glove Indonesia with the FDA for Powder Free Nitrile Examination Gloves (6mil), Tested For Use With Chemotherapy Drugs (blue.
| Device ID | K101630 |
| 510k Number | K101630 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE |
| Classification | Polymer Patient Examination Glove |
| Applicant | PT. SMART GLOVE INDONESIA JL RAYA MEDAN-LUBUK PAKAM KM19 TANJONG MORAWA B,TANJONG Morawa,deli Serdang,sumatera U, ID 20362 |
| Contact | Cho Sow Fong |
| Correspondent | Cho Sow Fong PT. SMART GLOVE INDONESIA JL RAYA MEDAN-LUBUK PAKAM KM19 TANJONG MORAWA B,TANJONG Morawa,deli Serdang,sumatera U, 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 | 2010-06-10 |
| Decision Date | 2010-09-07 |