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 | K060771 |
| 510k Number | K060771 |
| Device Name: | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE COLORED |
| Classification | Polymer Patient Examination Glove |
| Applicant | KOSSAN LATEX INDUSTRIES (M) SDN. BHD. LOT 16632, 5-1/4 MILES, JALAN MERU Klang, Selangor, MY 41050 |
| Contact | Lim K Hwa |
| Correspondent | Lim K Hwa KOSSAN LATEX INDUSTRIES (M) SDN. BHD. LOT 16632, 5-1/4 MILES, JALAN MERU Klang, Selangor, MY 41050 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-22 |
| Decision Date | 2006-05-01 |