The following data is part of a premarket notification filed by Shandong Binxiang Medical Products Co., Ltd. with the FDA for Powder-free Vinyl Patient Examination Gloves.
| Device ID | K131832 |
| 510k Number | K131832 |
| Device Name: | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHANDONG BINXIANG MEDICAL PRODUCTS CO., LTD. 12390 EAST END AVE. Chino, CA 91710 |
| Contact | Ray Zhou |
| Correspondent | Ray Zhou SHANDONG BINXIANG MEDICAL PRODUCTS CO., LTD. 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 | 2013-06-20 |
| Decision Date | 2014-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3408617XL1 | K131832 | 000 |
| 00810112471434 | K131832 | 000 |
| 00810112471380 | K131832 | 000 |
| 00810112471427 | K131832 | 000 |
| 00810112471410 | K131832 | 000 |
| 00810112471403 | K131832 | 000 |
| 00810112471397 | K131832 | 000 |
| 00850046161827 | K131832 | 000 |
| 00850046161797 | K131832 | 000 |
| 00850046161766 | K131832 | 000 |
| 00850046161735 | K131832 | 000 |
| 00850042242070 | K131832 | 000 |
| 00850042242063 | K131832 | 000 |
| 00850042242056 | K131832 | 000 |
| 00850042242049 | K131832 | 000 |
| 00810143550320 | K131832 | 000 |
| 00810143550290 | K131832 | 000 |
| 00810143550269 | K131832 | 000 |
| 00810112471441 | K131832 | 000 |
| 00810112471458 | K131832 | 000 |
| 00810112471465 | K131832 | 000 |
| B3408617S1 | K131832 | 000 |
| B3408617M1 | K131832 | 000 |
| B3408617L1 | K131832 | 000 |
| 80368001109082 | K131832 | 000 |
| 80368001109075 | K131832 | 000 |
| 60368001109064 | K131832 | 000 |
| 60368001109057 | K131832 | 000 |
| 00616784261706 | K131832 | 000 |
| 00616784261614 | K131832 | 000 |
| 00492450705701 | K131832 | 000 |
| 00649531920175 | K131832 | 000 |
| 00649531920168 | K131832 | 000 |
| 00649531920144 | K131832 | 000 |
| 00649531920120 | K131832 | 000 |
| 00810112471496 | K131832 | 000 |
| 00810112471489 | K131832 | 000 |
| 00810112471472 | K131832 | 000 |
| 00810143550238 | K131832 | 000 |