The following data is part of a premarket notification filed by Tk Hitech Technology Co., Ltd. with the FDA for Biotech Nitrile Examination Gloves.
| Device ID | K202419 |
| 510k Number | K202419 |
| Device Name: | BIOTECH Nitrile Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | TK Hitech Technology Co., Ltd. 1/221 Venish Irish Iris Watcharaphol Road Tha Rang, Bangkok, TH 10220 |
| Contact | Kanyapadsanan Suppipatthipbodee |
| Correspondent | Joyce Kwon Provision Consulting Group, Inc. 100 Barranca St. Suite 700 West Covina, CA 91791 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-24 |
| Decision Date | 2021-04-16 |