The following data is part of a premarket notification filed by Syntex Healthcare Products Co. Ltd. with the FDA for Syntex Powder-free Polymer-coated Latex Examination Glove.
| Device ID | K022146 |
| 510k Number | K022146 |
| Device Name: | SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | SYNTEX HEALTHCARE PRODUCTS CO. LTD. NO. 1 FANJIAZHUNG INDUSTRIAL ZONE Xinji City, Hebei Province, CN 052360 |
| Contact | Tan Swu Choon |
| Correspondent | Tan Swu Choon SYNTEX HEALTHCARE PRODUCTS CO. LTD. NO. 1 FANJIAZHUNG INDUSTRIAL ZONE Xinji City, Hebei Province, CN 052360 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-02 |
| Decision Date | 2002-09-03 |