| Primary Device ID | 10634916779094 | 
| NIH Device Record Key | 350844f9-3006-4bf3-a35d-b44d98b2db7f | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Isolation Gown, Reusable | 
| Version Model Number | 666405F5 | 
| Catalog Number | 666405F5 | 
| Company DUNS | 006999858 | 
| Company Name | STANDARD TEXTILE CO., INC. | 
| Device Count | 60 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | true |