The following data is part of a premarket notification filed by Viet Glove Corporation with the FDA for Powder Free Blue Nitrile Examination Glove.
| Device ID | K153562 |
| 510k Number | K153562 |
| Device Name: | Powder Free Blue Nitrile Examination Glove |
| Classification | Polymer Patient Examination Glove |
| Applicant | Viet Glove Corporation Cau Sat Hamlet, Lai Hung Commune Ben Cat District Bau Bang Province, VN |
| Contact | Pham Ngoc Thanh |
| Correspondent | Terence Lim Viet Glove Corporation Cau Sat Hamlet, Lai Hung Commune Ben Cat District Bau Bang Province, VN |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-14 |
| Decision Date | 2016-04-01 |