CAP'N K

GUDID 00810169800874

PRIME SOLUTIONS, INC.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID00810169800874
NIH Device Record Key4fbf0415-1573-44f8-930c-cba537050105
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAP'N K
Version Model NumberMWSPN/M
Company DUNS093300590
Company NamePRIME SOLUTIONS, INC.
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810169800829 [Primary]
GS100810169800874 [Package]
Contains: 00810169800829
Package: CASE [10 Units]
In Commercial Distribution
GS110810169800826 [Unit of Use]

FDA Product Code

LZAPolymer Patient Examination Glove

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-23
Device Publish Date2025-06-14