The following data is part of a premarket notification filed by Tangshan Jiteng Plastic Products Co., Ltd. with the FDA for Synthetic, Powder-free Nitrile Examination Gloves.
| Device ID | K101943 |
| 510k Number | K101943 |
| Device Name: | SYNTHETIC, POWDER-FREE NITRILE EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | TANGSHAN JITENG PLASTIC PRODUCTS CO., LTD. 12390 EAST END AVE Chino, CA 91710 |
| Contact | Frank Liu |
| Correspondent | Frank Liu TANGSHAN JITENG PLASTIC PRODUCTS CO., LTD. 12390 EAST END AVE Chino, CA 91710 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-12 |
| Decision Date | 2010-11-08 |
| Summary: | summary |