The following data is part of a premarket notification filed by Nam Viet Glove Joint Stock Company with the FDA for Powder Free Nitrile Examination Gloves (blue).
Device ID | K162113 |
510k Number | K162113 |
Device Name: | Powder Free Nitrile Examination Gloves (Blue) |
Classification | Polymer Patient Examination Glove |
Applicant | NAM VIET GLOVE JOINT STOCK COMPANY HAMLET 7, PHUOC BINH COMMUNE LONG THANH DISTRICT Ho Chi Minh, VN 815300 |
Contact | Ooi Loon Seng |
Correspondent | Ooi Loon Seng NAM VIET GLOVE JOINT STOCK COMPANY HAMLET 7, PHUOC BINH COMMUNE LONG THANH DISTRICT Ho Chi Minh, VN 815300 |
Product Code | LZA |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-07-29 |
Decision Date | 2016-11-07 |
Summary: | summary |