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 |