The following data is part of a premarket notification filed by Wangda Plastic Co., Ltd with the FDA for Powder-free Vinyl Patient Examination Gloves.
| Device ID | K110944 |
| 510k Number | K110944 |
| Device Name: | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | WANGDA 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 WANGDA 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 | 2011-04-04 |
| Decision Date | 2011-09-01 |
| Summary: | summary |