The following data is part of a premarket notification filed by Shandong Langtai International Trade Co., Ltd. with the FDA for Nbr Synthetic Nitrile Examination Gloves.
| Device ID | K212436 |
| 510k Number | K212436 |
| Device Name: | NBR Synthetic Nitrile Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Shandong Langtai International Trade Co., Ltd. 8/F,office Building,Weiqiao Aluminum Deep Processing Industrial Park ,Chanshan Town,Zouping Binzhou, CN 256206 |
| Contact | Ping Wang |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lujiazui Rd.,Pudong Shanghai, CN 200120 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-04 |
| Decision Date | 2021-12-23 |