The following data is part of a premarket notification filed by Giga-drive Sdn, Bhd with the FDA for Non Sterile Powder Free Nitrile Examination Gloves, Blue.
| Device ID | K083156 |
| 510k Number | K083156 |
| Device Name: | NON STERILE POWDER FREE NITRILE EXAMINATION GLOVES, BLUE |
| Classification | Polymer Patient Examination Glove |
| Applicant | GIGA-DRIVE SDN, BHD 17A JALAN DATO HAJI MEGAT KHAS TAMAN BANDAR UTAMA Ipoh, Perak, MY 31400 |
| Contact | Ian Ng Tze Cheu |
| Correspondent | Ian Ng Tze Cheu GIGA-DRIVE SDN, BHD 17A JALAN DATO HAJI MEGAT KHAS TAMAN BANDAR UTAMA Ipoh, Perak, MY 31400 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-24 |
| Decision Date | 2009-05-08 |