The following data is part of a premarket notification filed by Zibo Hengde Plastic & Rubber Products Co., Ltd. with the FDA for Powdered Vinyl Patient Examination Gloves.
| Device ID | K070008 |
| 510k Number | K070008 |
| Device Name: | POWDERED VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | ZIBO HENGDE PLASTIC & RUBBER PRODUCTS CO., LTD. NO. 209 BEI SI HUAN ZHONG ROAD Beijing, CN 10083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan ZIBO HENGDE PLASTIC & RUBBER PRODUCTS CO., LTD. NO. 209 BEI SI HUAN ZHONG ROAD 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 | 2007-01-03 |
| Decision Date | 2007-02-08 |
| Summary: | summary |