The following data is part of a premarket notification filed by Kossan Latex Industries (m) Sdn. Bhd. with the FDA for Powdered Nitrile Examination Glove, Blue Or White (non-colored).
| Device ID | K992497 |
| 510k Number | K992497 |
| Device Name: | POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) |
| Classification | Polymer Patient Examination Glove |
| Applicant | KOSSAN LATEX INDUSTRIES (M) SDN. BHD. LOT 16632, 5-1/4 MILES, JALAN MERU Kelang, Selangor, MY 41050 |
| Contact | Lim Kwan Hwa |
| Correspondent | Lim Kwan Hwa KOSSAN LATEX INDUSTRIES (M) SDN. BHD. LOT 16632, 5-1/4 MILES, JALAN MERU Kelang, 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 | 1999-07-26 |
| Decision Date | 1999-08-25 |