The following data is part of a premarket notification filed by Anhui Intco Medical Products Co. Ltd with the FDA for Powder-free Clear Vinyl Patient Examination Gloves.
| Device ID | K190095 |
| 510k Number | K190095 |
| Device Name: | Powder-Free Clear Vinyl Patient Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Anhui Intco Medical Products Co. Ltd No. 1 Haitang Road, Suixi District Economic Development Area Huaibei City, Anhui Huaibei, CN 235100 |
| Contact | Jacken Cai |
| Correspondent | Derek Tian Intco Medical Industries, Inc. 805 Barrington Ave Ontario, CA 91764 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-22 |
| Decision Date | 2019-06-20 |