The following data is part of a premarket notification filed by Tangshan Dar Plastic & Rubber Products Co. Ltd. with the FDA for Powder-free Vinyl Patient Examination Gloves.
| Device ID | K082648 |
| 510k Number | K082648 |
| Device Name: | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | TANGSHAN DAR PLASTIC & RUBBER PRODUCTS CO. LTD. RM.1606 BLDG.1 JIANXIANG YUAN NO.209 BEI SI HUAN ZHONG RD Beijing, CN 10083 |
| Contact | Wang Jincheng |
| Correspondent | Wang Jincheng TANGSHAN DAR PLASTIC & RUBBER PRODUCTS CO. LTD. RM.1606 BLDG.1 JIANXIANG YUAN NO.209 BEI SI HUAN ZHONG RD Beijing, CN 10083 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-11 |
| Decision Date | 2009-09-25 |
| Summary: | summary |