The following data is part of a premarket notification filed by Sunmax Vietnam Co. Ltd with the FDA for Sunmax Vietnam Co. Ltd Powder Free White Nitrile Examination Glove.
| Device ID | K101870 |
| 510k Number | K101870 |
| Device Name: | SUNMAX VIETNAM CO. LTD POWDER FREE WHITE NITRILE EXAMINATION GLOVE |
| Classification | Polymer Patient Examination Glove |
| Applicant | SUNMAX VIETNAM CO. LTD 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
| Contact | Jigar Shah |
| Correspondent | Jigar Shah SUNMAX VIETNAM CO. LTD 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-06 |
| Decision Date | 2010-12-20 |
| Summary: | summary |