The following data is part of a premarket notification filed by Central Medicare Sdn Bhd with the FDA for Powder Free Nitrile Examination Gloves White Colored Non-sterile.
| Device ID | K103734 |
| 510k Number | K103734 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVES WHITE COLORED NON-STERILE |
| Classification | Polymer Patient Examination Glove |
| Applicant | CENTRAL MEDICARE SDN BHD 1930 BREA CANYON ROAD, #240,DIAMOND BAR Diamond Bar, CA 91765 |
| Contact | Nick Wang |
| Correspondent | Nick Wang CENTRAL MEDICARE SDN BHD 1930 BREA CANYON ROAD, #240,DIAMOND BAR Diamond Bar, CA 91765 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-22 |
| Decision Date | 2011-08-19 |
| Summary: | summary |