The following data is part of a premarket notification filed by Thai Rubber Industry Company Limited with the FDA for Comfortpro Blue Nitrile Examination Gloves Powder Free.
| Device ID | K212850 |
| 510k Number | K212850 |
| Device Name: | ComfortPro Blue Nitrile Examination Gloves Powder Free |
| Classification | Polymer Patient Examination Glove |
| Applicant | Thai Rubber Industry Company Limited 738 Moo 5, Manam Koo Pluakdaeng, TH 21140 |
| Contact | Supawadee Phoungthong |
| Correspondent | Manoj Zacharias Liberty Management Group Ltd. 75 Executive Dr. STE 114, Aurora, IL 60504 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-07 |
| Decision Date | 2021-12-10 |