The following data is part of a premarket notification filed by Vietglove Corporation with the FDA for Powder Free Black Nitrile Examination Glove.
Device ID | K201428 |
510k Number | K201428 |
Device Name: | Powder Free Black Nitrile Examination Glove |
Classification | Polymer Patient Examination Glove |
Applicant | Vietglove Corporation Cau Sat Hamlet, Lai Hung Commune, Bau Bang District, Binh Duong Province Bingh Duong, VN 72600 |
Contact | Pham Ngoc Thanh |
Correspondent | Terence Lim Vietglove Corporation Cau Sat Hamlet, Lai Hung Commune, Bau Bang District, Binh Duong Province Bingh Duong, VN 72600 |
Product Code | LZA |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-05-29 |
Decision Date | 2021-06-24 |