The following data is part of a premarket notification filed by Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd with the FDA for Disposable Sterilized Latex Surgical Gloves.
| Device ID | K211953 |
| 510k Number | K211953 |
| Device Name: | Disposable Sterilized Latex Surgical Gloves |
| Classification | Surgeon's Gloves |
| 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 A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shanghai, CN 200040 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-23 |
| Decision Date | 2022-05-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16972267280000 | K211953 | 000 |
| 16972267280147 | K211953 | 000 |
| 16972267280130 | K211953 | 000 |
| 16972267280123 | K211953 | 000 |
| 16972267280116 | K211953 | 000 |
| 16972267280109 | K211953 | 000 |