The following data is part of a premarket notification filed by Xinwei (shandong) Plastic And Rubber Products Co., with the FDA for Powder-free Nitrile Patient Examination Gloves, Blue Color.
| Device ID | K121992 |
| 510k Number | K121992 |
| Device Name: | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR |
| Classification | Polymer Patient Examination Glove |
| Applicant | XINWEI (SHANDONG) PLASTIC AND RUBBER PRODUCTS CO., 12390 EAST END AVE. Chino, CA 91710 |
| Contact | Frank Liu |
| Correspondent | Frank Liu XINWEI (SHANDONG) PLASTIC AND RUBBER PRODUCTS CO., 12390 EAST END AVE. Chino, CA 91710 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-06 |
| Decision Date | 2012-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840064620789 | K121992 | 000 |
| B845NGPF10353 | K121992 | 000 |
| B845NGPF10363 | K121992 | 000 |
| B845NGPF10373 | K121992 | 000 |
| 00850054429322 | K121992 | 000 |
| 00850054429957 | K121992 | 000 |
| 00850054429964 | K121992 | 000 |
| 00850054429971 | K121992 | 000 |
| 00850046814808 | K121992 | 000 |
| 00850046814815 | K121992 | 000 |
| 00850046814822 | K121992 | 000 |
| 00850046814839 | K121992 | 000 |
| 00850046814846 | K121992 | 000 |
| 00850046814853 | K121992 | 000 |
| 00850046814860 | K121992 | 000 |
| 00840064620635 | K121992 | 000 |
| 00840064620765 | K121992 | 000 |
| 00840064620772 | K121992 | 000 |
| B845NGPF10343 | K121992 | 000 |