The following data is part of a premarket notification filed by Zibo Yingbo Medical Products, Inc. with the FDA for Powder-free Vinyl Patient Examination Gloves.
| Device ID | K102444 |
| 510k Number | K102444 |
| Device Name: | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | ZIBO YINGBO MEDICAL PRODUCTS, INC. 12390 EAST END AVE. Chino, CA 91710 |
| Contact | Frank Liu |
| Correspondent | Frank Liu ZIBO YINGBO MEDICAL PRODUCTS, INC. 12390 EAST END AVE. 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 | 2010-08-26 |
| Decision Date | 2010-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812277034851 | K102444 | 000 |
| 00810143550238 | K102444 | 000 |
| 00810143550269 | K102444 | 000 |
| 00810143550290 | K102444 | 000 |
| 00810143550320 | K102444 | 000 |
| 00672047000215 | K102444 | 000 |
| 00672047000222 | K102444 | 000 |
| 00672047000239 | K102444 | 000 |
| 00672047000246 | K102444 | 000 |
| 00812277034820 | K102444 | 000 |
| 00812277034837 | K102444 | 000 |
| 00812277034844 | K102444 | 000 |
| 06970245755260 | K102444 | 000 |