Textile Donning Gloves 593RPRS

GUDID 07611711872775

A device made of natural latex intended to assist patients and caregivers in donning and removing compression stockings and garments without causing damage to the stocking (e.g. from nails, jewelry). This device will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

SIGVARIS INC

Utility glove
Primary Device ID07611711872775
NIH Device Record Key487bfed0-a8ec-416f-a093-b554cbfbdfa1
Commercial Distribution StatusIn Commercial Distribution
Brand NameTextile Donning Gloves
Version Model Number593RPRS
Catalog Number593RPRS
Company DUNS189738719
Company NameSIGVARIS INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com
Phone+1(800)322-7744
Emailsigvariscares@sigvaris.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS107611711872775 [Primary]

FDA Product Code

IKXAid, Transfer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-24
Device Publish Date2025-07-16

On-Brand Devices [Textile Donning Gloves]

07611711872805A device made of natural latex intended to assist patients and caregivers in donning and removin
07611711872799A device made of natural latex intended to assist patients and caregivers in donning and removin
07611711872782A device made of natural latex intended to assist patients and caregivers in donning and removin
07611711872775A device made of natural latex intended to assist patients and caregivers in donning and removin
07611711872768A device made of natural latex intended to assist patients and caregivers in donning and removin

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