The following data is part of a premarket notification filed by Pt. Smart Glove Indonesia with the FDA for Powder Free Nitrile Examination Gloves, Black.
| Device ID | K092034 |
| 510k Number | K092034 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVES, BLACK |
| 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 | Soon Tuck Kwan |
| Correspondent | Soon Tuck Kwan 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 | 2009-07-06 |
| Decision Date | 2009-10-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30851253007893 | K092034 | 000 |
| 30851253007886 | K092034 | 000 |
| 30851253007879 | K092034 | 000 |
| 30851253007862 | K092034 | 000 |