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 C (nitrile Gloves).
| Device ID | K212290 |
| 510k Number | K212290 |
| Device Name: | Examination Gloves -Type C (Nitrile Gloves) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd 316 National Road, Xinju, Changshan Town, Jinxian County Nanchang, CN 331724 |
| Contact | Jenny Huang |
| Correspondent | Evan Hu Shanghai Mind-link Consulting Co., Ltd. 639 Jiaozhou Road Shanghai, CN 200040 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-21 |
| Decision Date | 2021-10-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26972267280182 | K212290 | 000 |
| 26972267280175 | K212290 | 000 |
| 26972267280168 | K212290 | 000 |
| 26972267280151 | K212290 | 000 |