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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810120952413 | K201428 | 000 |
| 00810120952383 | K201428 | 000 |
| 00810120952352 | K201428 | 000 |
| 00810120952321 | K201428 | 000 |
| 00810120952420 | K201428 | 000 |
| 00810120952260 | K201428 | 000 |