The following data is part of a premarket notification filed by Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd with the FDA for Examination Gloves-type A(latex Gloves).
| Device ID | K214017 |
| 510k Number | K214017 |
| Device Name: | Examination Gloves-Type A(Latex Gloves) |
| Classification | Latex Patient Examination Glove |
| Applicant | Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd No. 316 National Road, Xinju, Changshan Town Jinxian County Nanchang, CN 331724 |
| Contact | Jenny Huang |
| Correspondent | Alice Huang Shanghai Mind-link Business Consulting Co., Ltd. Room 8208, Second Floor, No 1399, Jiangyue Road Minhang District Shanghai, CN 201114 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-22 |
| Decision Date | 2022-07-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26972267280359 | K214017 | 000 |
| 26972267280335 | K214017 | 000 |
| 26972267280328 | K214017 | 000 |
| 26972267280311 | K214017 | 000 |