Duns Number:256880576
Device Description: Ocean Pacific Lab Master - Nitrile Medical Examination Gloves - Chemotherapy Tested - Text Ocean Pacific Lab Master - Nitrile Medical Examination Gloves - Chemotherapy Tested - Textured Fingertips - Powder Free - Non-Sterile - Indigo - X-Large
Catalog Number
OPXL-LM2
Brand Name
Ocean Pacific
Version/Model Number
OPXL-LM2
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
K182383,K182383,K182383
Product Code
LZC
Product Code Name
Patient Examination Glove, Specialty
Public Device Record Key
0af2cb33-d769-445a-8214-c777f2684d6d
Public Version Date
October 05, 2022
Public Version Number
1
DI Record Publish Date
September 27, 2022
Package DI Number
20686864042390
Quantity per Package
10
Contains DI Package
10686864042393
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 |