The following data is part of a premarket notification filed by Tangshan Hengda Plastic Products Co., Ltd with the FDA for Powder Free Vinyl Patient Examination Gloves, Colored (white).
| Device ID | K102558 |
| 510k Number | K102558 |
| Device Name: | POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | TANGSHAN HENGDA PLASTIC PRODUCTS CO., LTD #209 BEI SI HUAN ZHONG ROAD RM 1606 BLDG 1 JIANXIANG YUAN Haidian District, Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan TANGSHAN HENGDA PLASTIC PRODUCTS CO., LTD #209 BEI SI HUAN ZHONG ROAD RM 1606 BLDG 1 JIANXIANG YUAN 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 | 2010-09-07 |
| Decision Date | 2010-11-12 |
| Summary: | summary |