The following data is part of a premarket notification filed by Viet Glove Corporation with the FDA for Powder Free Latex Examination Glove, Polymer Coated.
| Device ID | K170094 |
| 510k Number | K170094 |
| Device Name: | POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED |
| Classification | Latex 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 | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-11 |
| Decision Date | 2017-06-23 |