The following data is part of a premarket notification filed by Zhang Jia Gang Huayuan Plastic Co. Ltd. with the FDA for Powder-free Vinyl Patient Examination Gloves.
| Device ID | K091661 |
| 510k Number | K091661 |
| Device Name: | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | ZHANG JIA GANG HUAYUAN PLASTIC CO. LTD. RM.1606 BLDG.1, JIANXIANG YUAN NO.209 BEI SI HUAN ZHONG RD Haidian District, Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan ZHANG JIA GANG HUAYUAN PLASTIC CO. LTD. RM.1606 BLDG.1, JIANXIANG YUAN NO.209 BEI SI HUAN ZHONG RD Haidian District, 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 | 2009-06-09 |
| Decision Date | 2009-07-27 |
| Summary: | summary |