The following data is part of a premarket notification filed by Shandong Zhiyuan Medical Products Co., Ltd. with the FDA for Powder-free Vinyl Patient Examination Gloves, Yellow Color.
| Device ID | K112266 |
| 510k Number | K112266 |
| Device Name: | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHANDONG ZHIYUAN MEDICAL PRODUCTS CO., LTD. 12390 EAST END AVENUE Chino, CA 91710 |
| Contact | Frank Liu |
| Correspondent | Frank Liu SHANDONG ZHIYUAN MEDICAL PRODUCTS CO., LTD. 12390 EAST END AVENUE Chino, CA 91710 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-08 |
| Decision Date | 2012-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850042242131 | K112266 | 000 |
| 00810112471311 | K112266 | 000 |
| 00810112471205 | K112266 | 000 |
| 00810112471212 | K112266 | 000 |
| 00810112471229 | K112266 | 000 |
| 00810112471236 | K112266 | 000 |
| 00810112471243 | K112266 | 000 |
| 00810112471250 | K112266 | 000 |
| 00810112471328 | K112266 | 000 |
| 00810112471335 | K112266 | 000 |
| 00810112471342 | K112266 | 000 |
| 00810112471267 | K112266 | 000 |
| 00810112471304 | K112266 | 000 |
| 00850042242148 | K112266 | 000 |
| 00850042242155 | K112266 | 000 |
| 00850042242162 | K112266 | 000 |
| 00850042242179 | K112266 | 000 |
| 00850042242186 | K112266 | 000 |
| 00850042242193 | K112266 | 000 |
| 00850042242209 | K112266 | 000 |
| 00810112471274 | K112266 | 000 |
| 00810112471281 | K112266 | 000 |
| 00810112471298 | K112266 | 000 |
| 00810112471359 | K112266 | 000 |
| 00810112471366 | K112266 | 000 |
| 80368001109105 | K112266 | 000 |
| 80368001109112 | K112266 | 000 |
| 80368001109129 | K112266 | 000 |
| B340790222S1 | K112266 | 000 |
| B340790223M1 | K112266 | 000 |
| B340790224L1 | K112266 | 000 |
| B340790226XL1 | K112266 | 000 |
| B3408607L1 | K112266 | 000 |
| B3408607M1 | K112266 | 000 |
| B3408607S1 | K112266 | 000 |
| 80368001109099 | K112266 | 000 |
| 00810112471199 | K112266 | 000 |
| 00810112471373 | K112266 | 000 |
| 00672047000130 | K112266 | 000 |
| 00672047000147 | K112266 | 000 |
| 00672047000154 | K112266 | 000 |
| 00672047000161 | K112266 | 000 |
| 00810112471175 | K112266 | 000 |
| 00810112471151 | K112266 | 000 |
| 00810112471168 | K112266 | 000 |
| 00810112471182 | K112266 | 000 |
| 00810112471144 | K112266 | 000 |
| B3408607XL1 | K112266 | 000 |