The following data is part of a premarket notification filed by Sunmax Enterprise Shanghai Co. Ltd. with the FDA for Powder-free Vinyl Patient Examination Gloves.
| Device ID | K964964 |
| 510k Number | K964964 |
| Device Name: | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SUNMAX ENTERPRISE SHANGHAI CO. LTD. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk SUNMAX ENTERPRISE SHANGHAI CO. LTD. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-11 |
| Decision Date | 1997-02-07 |