The following data is part of a premarket notification filed by Zibo Sinocare Plastic Products Co., Ltd. with the FDA for Powdered Vinyl Patient Examination Gloves, White (non-colored).
| Device ID | K051152 |
| 510k Number | K051152 |
| Device Name: | POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | ZIBO SINOCARE PLASTIC PRODUCTS CO., LTD. 209 BEI SI HUAN ZHONG ROAD HAIDIAN DISTRICT, BLDG. 1 Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan ZIBO SINOCARE PLASTIC PRODUCTS CO., LTD. 209 BEI SI HUAN ZHONG ROAD HAIDIAN DISTRICT, BLDG. 1 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 | 2005-05-04 |
| Decision Date | 2005-06-03 |
| Summary: | summary |