Duns Number:256880576
Device Description: Ocean Pacific Blue Lite - Nitrile Medical Examination Gloves - Chemotherapy Tested - Textu Ocean Pacific Blue Lite - Nitrile Medical Examination Gloves - Chemotherapy Tested - Textured Fingertips - Powder Free - Non-Sterile - Blue - X-Small
Catalog Number
OPXS-BL2
Brand Name
Ocean Pacific
Version/Model Number
OPXS-BL2
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K162095,K162095,K162095
Product Code
LZA
Product Code Name
Polymer Patient Examination Glove
Public Device Record Key
4af9398c-3565-4b48-a6a2-75b4b1db6eae
Public Version Date
October 05, 2022
Public Version Number
1
DI Record Publish Date
September 27, 2022
Package DI Number
20686864042451
Quantity per Package
10
Contains DI Package
10686864042454
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 2 |