Duns Number:070556204
Device Description: CURAPLEX VINYL GLOVES LG, 100/BX 10BX/CS
Catalog Number
CUR5603
Brand Name
Curaplex
Version/Model Number
CUR5603
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
K102444,K102444,K102444
Product Code
LYZ
Product Code Name
Vinyl patient examination glove
Public Device Record Key
f3421e86-af6f-4c09-8283-9c45ee230c43
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 15, 2019
Package DI Number
00812277034844
Quantity per Package
10
Contains DI Package
00812277034769
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 471 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 540 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 1 |