Capn'K

GUDID 00810054145769

Solid Wing Wholesale Inc.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID00810054145769
NIH Device Record Keybdc8defa-caa3-4158-8af3-2ad5f724087e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCapn'K
Version Model NumberMWSPN-XL
Company DUNS118968508
Company NameSolid Wing Wholesale 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 Batchtrue
Serial Numbertrue
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
GS100810054145721 [Primary]
GS100810054145769 [Package]
Contains: 00810054145721
Package: [10 Units]
In Commercial Distribution
GS110810054145728 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2024-02-13
Device Publish Date2024-02-05