Duns Number:080344373
Device Description: Patient examination glove made from nitrile compound, blue color, powder free and non-ster Patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. See product packaging for size identification. Carton of 100 pieces/inner box.
Catalog Number
-
Brand Name
LYDUS Nitrile Examination Gloves, Powder Free
Version/Model Number
FRSNS-LYDUSNTRL
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
K203191,K203191
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
9fc02495-39a9-44bd-a1ec-a294d84830ef
Public Version Date
March 07, 2022
Public Version Number
1
DI Record Publish Date
February 27, 2022
Package DI Number
00711583360954
Quantity per Package
10
Contains DI Package
00711583361104
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |