The following data is part of a premarket notification filed by Syntex Healthcare Products Co. Ltd. with the FDA for Syntex Powder-free Nitrile Examination Glove, Tested For Chemotherapy.
| Device ID | K042226 |
| 510k Number | K042226 |
| Device Name: | SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY |
| Classification | Polymer Patient Examination Glove |
| Applicant | SYNTEX HEALTHCARE PRODUCTS CO. LTD. 590 W. CENTRAL AVENUE, #D Brea, CA 92821 |
| Contact | James Chu |
| Correspondent | James Chu SYNTEX HEALTHCARE PRODUCTS CO. LTD. 590 W. CENTRAL AVENUE, #D Brea, CA 92821 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-17 |
| Decision Date | 2004-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30818634020179 | K042226 | 000 |
| 30818634020216 | K042226 | 000 |
| 30818634020209 | K042226 | 000 |
| 30818634020193 | K042226 | 000 |
| 30818634020186 | K042226 | 000 |