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 Gloves, Green, Non-sterile.
| Device ID | K123749 |
| 510k Number | K123749 |
| Device Name: | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE |
| Classification | Polymer Patient Examination Glove |
| Applicant | KOSSAN LATEX INDUSTRIES(M)SDN BHD LOT 16632, 5 1/4 MILES, JALAN MERU KLANG Selangor Darul Ehsan, MY 41050 |
| Contact | Cho Sow Fong |
| Correspondent | Cho Sow Fong KOSSAN LATEX INDUSTRIES(M)SDN BHD LOT 16632, 5 1/4 MILES, JALAN MERU KLANG Selangor Darul Ehsan, 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 | 2012-12-06 |
| Decision Date | 2013-03-01 |
| Summary: | summary |