Duns Number:256880576
Device Description: Ocean Pacific NeoNatural - Polychloroprene Medical Examination Gloves - Chemotherapy Teste Ocean Pacific NeoNatural - Polychloroprene Medical Examination Gloves - Chemotherapy Tested - Textured Fingertips - Powder Free - Non-Sterile - Chemical Resistant Emerald - X-Large
Catalog Number
1228-E
Brand Name
Ocean Pacific NeoNatural
Version/Model Number
1228-E
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
K981064,K981064,K981064
Product Code
LZA
Product Code Name
Polymer patient examination glove
Public Device Record Key
6ef6bf55-a556-477b-a44c-66e28b9157fe
Public Version Date
July 06, 2022
Public Version Number
1
DI Record Publish Date
June 28, 2022
Package DI Number
20686864056083
Quantity per Package
10
Contains DI Package
10686864056086
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 |