The following data is part of a premarket notification filed by Anhui Lntco Medical Products Co., Ltd. with the FDA for Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested For Use W/chemotherapy Drug.
| Device ID | K200093 |
| 510k Number | K200093 |
| Device Name: | Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested For Use W/Chemotherapy Drug |
| Classification | Polymer Patient Examination Glove |
| Applicant | Anhui Lntco Medical Products Co., Ltd. No. 1 Haitang Road, Suixi District Economic Development Area Huaibei City, CN 235100 |
| Contact | Jacken Cai |
| Correspondent | Jason Ji lntco Medical Industries, Inc. 805 Barrington Ave Ontario, CA 91764 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-16 |
| Decision Date | 2020-08-20 |