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, Blue Colored And White (non-colored). Non-sterile.
| Device ID | K111772 |
| 510k Number | K111772 |
| Device Name: | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE |
| Classification | Polymer Patient Examination Glove |
| Applicant | KOSSAN LATEX INDUSTRIES(M)SDN BHD LOT 6129,JALAN HAJI ABDUL MANAN, OFF JALAN MERU Klang, Selangor D.e., MY 41050 |
| Contact | Cho Sow Fong |
| Correspondent | Cho Sow Fong KOSSAN LATEX INDUSTRIES(M)SDN BHD LOT 6129,JALAN HAJI ABDUL MANAN, OFF JALAN MERU Klang, Selangor D.e., 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 | 2011-06-23 |
| Decision Date | 2011-10-20 |
| Summary: | summary |