The following data is part of a premarket notification filed by Gri Medical & Electrical Technology Co., Ltd with the FDA for Royalguard Surgical Gown, I600, Breathable.
| Device ID | K172445 |
| 510k Number | K172445 |
| Device Name: | RoyalGuard Surgical Gown, I600, Breathable |
| Classification | Gown, Surgical |
| Applicant | GRI Medical & Electrical Technology Co., Ltd 1805 Honggao Rd., 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 | 2017-08-14 |
| Decision Date | 2017-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10304040119157 | K172445 | 000 |
| 06931918194496 | K172445 | 000 |
| 06931918190184 | K172445 | 000 |
| 06931918188921 | K172445 | 000 |
| 06931918184473 | K172445 | 000 |
| 26931918179374 | K172445 | 000 |
| 06931918173859 | K172445 | 000 |
| 06931918147355 | K172445 | 000 |
| 26931918147083 | K172445 | 000 |
| 06931918143166 | K172445 | 000 |
| 06931918142565 | K172445 | 000 |
| 06931918141117 | K172445 | 000 |
| 26931918139200 | K172445 | 000 |
| 06931918126251 | K172445 | 000 |
| 26931918126194 | K172445 | 000 |
| 06931918122185 | K172445 | 000 |
| 26931918122165 | K172445 | 000 |
| 26931918197194 | K172445 | 000 |
| 06931918123717 | K172445 | 000 |
| 10304040119119 | K172445 | 000 |
| 10304040119102 | K172445 | 000 |
| 10304040119089 | K172445 | 000 |
| 10304040119065 | K172445 | 000 |
| 10304040119058 | K172445 | 000 |
| 10304040119034 | K172445 | 000 |
| 26931918135660 | K172445 | 000 |
| 26931918122523 | K172445 | 000 |
| 26931918195572 | K172445 | 000 |
| 26931918171736 | K172445 | 000 |
| 26931918138494 | K172445 | 000 |
| 26931918191314 | K172445 | 000 |
| 26931918190294 | K172445 | 000 |
| 26931918156085 | K172445 | 000 |
| 26931918145454 | K172445 | 000 |
| 06931918142664 | K172445 | 000 |
| 26931918117635 | K172445 | 000 |