The following data is part of a premarket notification filed by Tangshan Jiaxing Plastic Products Co., Lt with the FDA for Powder-free Vinyl Patient Examination Gloves.
| Device ID | K100392 |
| 510k Number | K100392 |
| Device Name: | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | TANGSHAN JIAXING PLASTIC PRODUCTS CO., LT ROOM 1606 BLDG. 1 JIANXIANG YUAN NO. 209 BEI SI HUAN ZHO Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan TANGSHAN JIAXING PLASTIC PRODUCTS CO., LT ROOM 1606 BLDG. 1 JIANXIANG YUAN NO. 209 BEI SI HUAN ZHO Beijing, CN 100083 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-16 |
| Decision Date | 2010-04-13 |
| Summary: | summary |