The following data is part of a premarket notification filed by Kossan Latex Industries(m)sdn Bhd with the FDA for Powder-free Nitrile Patient Examination Glove, White (non-colored) And Blue Colored.
| Device ID | K062764 |
| 510k Number | K062764 |
| Device Name: | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED |
| Classification | Patient Examination Glove, Specialty |
| Applicant | KOSSAN LATEX INDUSTRIES(M)SDN BHD LOT 6129,JALAN HAJI ABDUL MANAN, OFF JALAN MERU Klang, Selangor, MY 41050 |
| Contact | Lim Kwan Hwa |
| Correspondent | Lim Kwan Hwa KOSSAN LATEX INDUSTRIES(M)SDN BHD LOT 6129,JALAN HAJI ABDUL MANAN, OFF JALAN MERU Klang, Selangor, MY 41050 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-15 |
| Decision Date | 2007-02-27 |
| Summary: | summary |