The following data is part of a premarket notification filed by Azac Group with the FDA for Protect X Level 3 Isolation Gown.
| Device ID | K211538 |
| 510k Number | K211538 |
| Device Name: | Protect X Level 3 Isolation Gown |
| Classification | Gown, Isolation, Surgical |
| Applicant | AZAC Group 17870 Castleton St. Suite 121 City Of Industry, CA 91748 |
| Contact | Yen Ping Shan |
| Correspondent | Robert Seiple QPM Consulting, LLC 3817 Seville Rd Denton, TX 76205 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-18 |
| Decision Date | 2021-11-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20860005250060 | K211538 | 000 |
| 20860005250039 | K211538 | 000 |