The following data is part of a premarket notification filed by Vrg Khai Hoan Joint Stock Company with the FDA for Powder Free Nitrile Examination Glove.
| Device ID | K151208 |
| 510k Number | K151208 |
| Device Name: | Powder Free Nitrile Examination Glove |
| Classification | Polymer Patient Examination Glove |
| Applicant | VRG KHAI HOAN JOINT STOCK COMPANY CAU SAT HAMLET, LAI HUNG COMMUNE Ben Cat District,, VN |
| Contact | Pham Ngoc Thanh |
| Correspondent | Terence Lim VRG KHAI HOAN JOINT STOCK COMPANY CAU SAT HAMLET, LAI HUNG COMMUNE Ben Cat District,, VN |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-06 |
| Decision Date | 2015-09-14 |