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 |