The following data is part of a premarket notification filed by Siam Ntd Corporation Co., Ltd. with the FDA for Siam Ntd+ Nitrile Powder-free Examination Gloves.
| Device ID | K212085 |
| 510k Number | K212085 |
| Device Name: | Siam NTD+ Nitrile Powder-Free Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Siam NTD Corporation Co., Ltd. 120/259 Moo 1 Bueng Yitho Thanyaburi, TH 12130 |
| Contact | Taweesak Waideemaneetrakoon |
| Correspondent | Taweesak Waideemaneetrakoon Third Party Review Group 25 Independence Blvd Warren, None, NJ 07059 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-02 |
| Decision Date | 2021-12-11 |