The following data is part of a premarket notification filed by Sunmax Enterprise Shanghai Co. Ltd. with the FDA for Sunmax Enterprise Shanghai Co. Powder Free Blue Nitrile Patient Examination Glove Tested With Chemotherapy Drugs.
| Device ID | K090336 |
| 510k Number | K090336 |
| Device Name: | SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS |
| Classification | Polymer Patient Examination Glove |
| Applicant | SUNMAX ENTERPRISE SHANGHAI CO. LTD. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Jigar Shah |
| Correspondent | Jigar Shah SUNMAX ENTERPRISE SHANGHAI CO. LTD. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-10 |
| Decision Date | 2009-07-01 |
| Summary: | summary |