FDA.reportPublic FDA data

Wavy Donning Gloves

Primary DI
00745129215286
Brand
Wavy Donning Gloves
Company
SIGVARIS INC
Model
590R
Catalog number
590RPRL
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
2016-12-05
Public version status
Update
Distribution status
Not 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
00745129184353PackageGS112Not in Commercial Distribution
00745129215286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00745129184353007451291843537451291843530745129184353
00745129215286007451292152867451292152860745129215286

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure sock/stocking, single-useA garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is intended for use in the home or a clinical setting. This is a single-use device.

Device Sizes#

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

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
00745129335069Envelo Arm Wrap Small Short Beige3111-ARS or 221093111-ARS2026-07-22
00745129335076Envelo Arm Wrap Small Regular Beige3111-ARR or 221103111-ARR2026-07-22
00745129335083Envelo Arm Wrap Small Long Beige3111-ARL or 221113111-ARL2026-07-22
00745129335090Envelo Arm Wrap Max Small Short Beige3111-AMS or 221123111-AMS2026-07-22
00745129335106Envelo Arm Wrap Max Small Regular Beige3111-AMR or 221133111-AMR2026-07-22
00745129335113Envelo Arm Wrap Max Small Long Beige3111-AML or 221143111-AML2026-07-22
00745129335120Envelo Arm Wrap Medium Short Beige3112-ARS or 221153112-ARS2026-07-22
00745129335137Envelo Arm Wrap Medium Regular Beige3112-ARR or 221163112-ARR2026-07-22
00745129335144Envelo Arm Wrap Medium Long Beige3112-ARL or 221173112-ARL2026-07-22
00745129335151Envelo Arm Wrap Max Medium Short Beige3112-AMS or 221183112-AMS2026-07-22
00745129335168Envelo Arm Wrap Max Medium Regular Beige3112-AMR or 221193112-AMR2026-07-22
00745129335175Envelo Arm Wrap Max Medium Long Beige3112-AML or 221203112-AML2026-07-22
00745129335182Envelo Arm Wrap Large Short Beige3113-ARS or 221213113-ARS2026-07-22
07613378196126862P-CUSTOM ECF2 AT1L SoftTop FEM °° Black3206063206062026-07-22
07613378196522862P-CUSTOM ECF2 AT SoftTop MEN Black3205663205662026-07-22
07613378196911862P-CUSTOM ECF2 AT SoftTop MEN °° Caramel3205273205272026-07-22
07613378197307862P-CUSTOM ECF2 AT SoftTop MEN Caramel3204883204882026-07-22
07613378197697862P-CUSTOM ECF2 AT SoftTop MEN °° Grey3204493204492026-07-22
07613378198083862P-CUSTOM ECF2 AT SoftTop MEN Grey3204103204102026-07-22
07613378198472862P-CUSTOM ECF2 AT SoftTop MEN °° Savanna3203713203712026-07-22

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