The following data is part of a premarket notification filed by Ping An Medical Products Co., Ltd. with the FDA for Vinyl Patient Examination Gloves.
| Device ID | K182115 |
| 510k Number | K182115 |
| Device Name: | Vinyl Patient Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Ping An Medical Products Co., Ltd. Zhe Ji Road, High-tech Industrial Zone Of Hukou County Jiu Jiang, CN 332000 |
| Contact | Fu Dong Zhang |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738, Shangcheng Rd., Pudong Shanghai, CN 200120 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-06 |
| Decision Date | 2018-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20686864046404 | K182115 | 000 |
| 20686864001540 | K182115 | 000 |
| 20686864001557 | K182115 | 000 |
| 20686864014793 | K182115 | 000 |
| 00686864059592 | K182115 | 000 |
| 00686864059516 | K182115 | 000 |
| 20686864015615 | K182115 | 000 |
| 20686864046381 | K182115 | 000 |
| 20686864046398 | K182115 | 000 |
| 20686864001526 | K182115 | 000 |