The following data is part of a premarket notification filed by Tangshan Hengtong Plastic Products Co. with the FDA for Powder-free Vinyl Patient Examination Gloves.
| Device ID | K100324 |
| 510k Number | K100324 |
| Device Name: | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | TANGSHAN HENGTONG PLASTIC PRODUCTS CO. JIANXIANG YUAN NO. 209 BEI SI HUAN ZHO Chu Xiaoan, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan TANGSHAN HENGTONG PLASTIC PRODUCTS CO. JIANXIANG YUAN NO. 209 BEI SI HUAN ZHO Chu Xiaoan, 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 | 2010-02-04 |
| Decision Date | 2010-03-29 |
| Summary: | summary |