The following data is part of a premarket notification filed by Gri Medical & Electrical Technology Co., Ltd. with the FDA for Comfortguard Plus Surgical Gown, I500, Comfortguard Surgical Gown, I500.
| Device ID | K162442 |
| 510k Number | K162442 |
| Device Name: | ComfortGuard Plus Surgical Gown, I500, ComfortGuard Surgical Gown, I500 |
| Classification | Gown, Surgical |
| Applicant | GRI MEDICAL & ELECTRICAL TECHNOLOGY CO., LTD. 1805 HONGGAO ROAD, XIUZHOU INDUSTRY ZONE Jiaxing, CN 314031 |
| Contact | Martin D. Paugh |
| Correspondent | Harry L. Shaffer Sterilization Consulting Services, LLC 10051 Oak Leaf Way Highlands Ranch, CO 80129 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-31 |
| Decision Date | 2016-12-12 |
| Summary: | summary |