Duns Number:279456896
Device Description: Standard isolation gown with cotton cuffs, sterile with polypropylene layer 30g/m².Availab Standard isolation gown with cotton cuffs, sterile with polypropylene layer 30g/m².Available in 4 sizes for the best fit: S, M, L, XLEO sterilised with a 3 year shelf-life
Catalog Number
HY-50027
Brand Name
HYGITECH
Version/Model Number
HY-50027
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K121152,K121152,K121152
Product Code
FYA
Product Code Name
Gown, Surgical
Public Device Record Key
bd89bbe6-7a37-46a9-811d-71f67afac371
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
December 15, 2020
Package DI Number
03615140002127
Quantity per Package
30
Contains DI Package
03615140002110
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 87 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |