FDA.reportPublic FDA data

Textile Donning Gloves

Primary DI
07611711872805
Brand
Textile Donning Gloves
Company
SIGVARIS INC
Model
593RPRXL
Catalog number
593RPRXL
Device description
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.
Published
2025-07-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKXAid, Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKXAid, TransferPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611711872805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611711872805076117118728057611711872805

GMDN Terms#

Term, Definition table
TermDefinition
Utility gloveA hand-worn device intended to be used by healthcare personnel to protect the hands from contamination and/or injury during paraclinical/non-clinical activities (e.g., handling waste, instrument reprocessing). It may be available in a variety of forms or with specific attributes (e.g., rubber, reinforced, heat resistant, with extended sleeve), however is not intended to protect from extreme cold/cryogenic temperatures (i.e., not a cryogenic safety glove). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)322-7744sigvariscares@sigvaris.com

Regulatory Flags#

DUNS number
189738719
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613378196157862W-CUSTOM ECF2 AGT WaistAttachment UNI °° Black3206033206032026-05-18
07613378196164862T-CUSTOM ECF2 AG SoftTop UNI °° Black3206023206022026-05-18
07613378196553862T-CUSTOM ECF2 AG SoftTop UNI Black3205633205632026-05-18
07613378196560862N-CUSTOM ECF2 AG SensinovaUnisex UNI Black3205623205622026-05-18
07613378196942862T-CUSTOM ECF2 AG SoftTop UNI °° Caramel3205243205242026-05-18
07613378197338862T-CUSTOM ECF2 AG SoftTop UNI Caramel3204853204852026-05-18
07613378197345862N-CUSTOM ECF2 AG SensinovaUnisex UNI Caramel3204843204842026-05-18
07613378197727862T-CUSTOM ECF2 AG SoftTop UNI °° Grey3204463204462026-05-18
07613378198113862T-CUSTOM ECF2 AG SoftTop UNI Grey3204073204072026-05-18
07613378198120862N-CUSTOM ECF2 AG SensinovaUnisex UNI Grey3204063204062026-05-18
07613378198502862T-CUSTOM ECF2 AG SoftTop UNI °° Savanna3203683203682026-05-18
07613378198892862T-CUSTOM ECF2 AG SoftTop UNI Savanna3203293203292026-05-18
07613378198908862N-CUSTOM ECF2 AG SensinovaUnisex UNI Savanna3203283203282026-05-18
07613378199288862T-CUSTOM ECF2 AG SoftTop UNI °° Skin3202903202902026-05-18
07613378199677862T-CUSTOM ECF2 AG SoftTop UNI Skin3202513202512026-05-18
07613378199684862N-CUSTOM ECF2 AG SensinovaUnisex UNI Skin3202503202502026-05-18
07613378277504862N-CUSTOM ECF2 AG SensinovaUnisex UNI marine3555233555232026-05-18
07613378277511862T-CUSTOM ECF2 AG SoftTop UNI marine3555243555242026-05-18
07613378277900862T-CUSTOM ECF2 AG SoftTop UNI °° marine3555633555632026-05-18
00745129334581422C Motion Thermo Wool 20-30mmHG U LL Denim MSTRP422CLL39 or 22061422CLL392026-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00689281037334"Easy Mount™ Grab Bar, 1.25x12"", Brushed Stainless"Healthcraft Products Inc.IKX2026-04-14
10194484320772CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320789CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320796CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320802CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320819CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320826CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320833CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320840CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320857CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320864CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320871CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320895CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320901CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320918CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320925CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320932CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320949CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320956CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320963CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320970CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320987CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320994CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484321007CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484321014CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484321021CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484321038CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484321045CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484321052CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484321069CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30