The following data is part of a premarket notification filed by Suzhou Shengyuda Plastic Products Co., Ltd. with the FDA for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored).
| Device ID | K100855 |
| 510k Number | K100855 |
| Device Name: | POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SUZHOU SHENGYUDA PLASTIC PRODUCTS CO., LTD. ROOM 1606 BUILDING, 1 JIAN XIANG YUAN NO. 209 BEI Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan SUZHOU SHENGYUDA PLASTIC PRODUCTS CO., LTD. ROOM 1606 BUILDING, 1 JIAN XIANG YUAN NO. 209 BEI 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 | 2010-03-26 |
| Decision Date | 2010-04-22 |
| Summary: | summary |