The following data is part of a premarket notification filed by Bestsafe Glove Co., Ltd. with the FDA for Best Glove-latex Powder Free Examination Glove.
| Device ID | K210253 |
| 510k Number | K210253 |
| Device Name: | Best Glove-Latex Powder Free Examination Glove |
| Classification | Latex Patient Examination Glove |
| Applicant | Bestsafe Glove CO., LTD. 52/43 Wat Khot Hin-Khao Phai Road, T. Tubma Muang Rayong, TH 21000 |
| Contact | Piyawat Chirasakulkarun |
| Correspondent | Piyawat Chirasakulkarun Bestsafe Glove CO., LTD. 52/43 Wat Khot Hin-Khao Phai Road, T. Tubma Muang Rayong, TH 21000 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-29 |
| Decision Date | 2021-11-05 |