The following data is part of a premarket notification filed by Syntex Healthcare Products Co. Ltd. with the FDA for Powder Free Nitrile Examination Gloves, Blue.
| Device ID | K102096 |
| 510k Number | K102096 |
| Device Name: | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE |
| Classification | Polymer Patient Examination Glove |
| Applicant | SYNTEX HEALTHCARE PRODUCTS CO. LTD. 3973 SCHAEFER AVE. Chino, CA 91710 |
| Contact | Kathy Liu |
| Correspondent | Kathy Liu SYNTEX HEALTHCARE PRODUCTS CO. LTD. 3973 SCHAEFER AVE. Chino, CA 91710 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-27 |
| Decision Date | 2010-10-04 |
| Summary: | summary |