FDA.report

WellCare

Primary DI
00850048808317
Brand
WellCare
Company
Wellcare International, Inc.
Model
WBK304
Device description
WellCare 3 mil exam Black nitrile gloves, size XL, 100pcs/box
Published
2024-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications

CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850048808324PrimaryGS10
10850048808314PrimaryGS10
00850048808317Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850048808324008500488083248500488083240850048808324
1085004880831410850048808314
00850048808317008500488083178500488083170850048808317

GMDN Terms

TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
106246039
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850048808270WellCareWBK3012024-02-19
00850048808287WellCareWBK3022024-02-19
00850048808294WellCareWBK3032024-02-19
20850048808274WellCareWBK3012024-02-19
00682670681965WellCareWNGBK5052022-11-21
00682670681842WellCareWNB7022022-11-21
00682670681859WellCareWNB7032022-11-21
00682670681866WellCareWNB7042022-11-21
00682670681873WellCareWNB7052022-11-21
00682670681880WellCareWBK7022022-11-21
00682670681897WellCareWBK7032022-11-21
00682670681903WellCareWBK7042022-11-21
00682670681910WellCareWBK7052022-11-21
00682670681927WellCareWNGBK5012022-11-21
00682670681934WellCareWNGBK5022022-11-21
00682670681941WellCareWNGBK5032022-11-21
00682670681958WellCareWNGBK5042022-11-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10194346659194EquateWAL-MART STORES, INC.LZA2026-03-24
10194346659200EquateWAL-MART STORES, INC.LZA2026-03-24
00850006162215Posi-ShieldClinical Supply CompanyLZA2026-03-24
00850006162192Posi-ShieldClinical Supply CompanyLZA2026-03-24
00850006162222Posi-ShieldClinical Supply CompanyLZA2026-03-24
00850006162239Posi-ShieldClinical Supply CompanyLZA2026-03-24
00850006162246Posi-ShieldClinical Supply CompanyLZA2026-03-24
00850006162185Posi-Shield AdvancedClinical Supply CompanyLZA2026-03-24
00850006162178Posi-Shield AdvancedClinical Supply CompanyLZA2026-03-24
00850006162161Posi-Shield AdvancedClinical Supply CompanyLZA2026-03-24
00850006162154Posi-Shield AdvancedClinical Supply CompanyLZA2026-03-24
00850006162147Posi-Shield AdvancedClinical Supply CompanyLZA2026-03-24
00850006162130Posi-Shield AdvancedClinical Supply CompanyLZA2026-03-24
00850006162352Posi-Prene Edge PinkClinical Supply CompanyLZA2026-03-24
00850006162369Posi-Prene Edge PinkClinical Supply CompanyLZA2026-03-24
00850006162376Posi-Prene Edge PinkClinical Supply CompanyLZA2026-03-24
00850006162345Posi-Prene Edge GreenClinical Supply CompanyLZA2026-03-24
00850006162321Posi-Prene Edge GreenClinical Supply CompanyLZA2026-03-24
00850006162314Posi-Prene Edge GreenClinical Supply CompanyLZA2026-03-24
00850006162307Posi-Prene Edge GreenClinical Supply CompanyLZA2026-03-24
00850006162048Posi-Prene GreenClinical Supply CompanyLZA2026-03-24
00850006162031Posi-Prene GreenClinical Supply CompanyLZA2026-03-24
00850006162024Posi-Prene GreenClinical Supply CompanyLZA2026-03-24
00850006162017Posi-Prene GreenClinical Supply CompanyLZA2026-03-24
00850006162000Posi-Prene GreenClinical Supply CompanyLZA2026-03-24
00850006162116Posi-Prene WhiteClinical Supply CompanyLZA2026-03-24
00850006162109Posi-Prene WhiteClinical Supply CompanyLZA2026-03-24
00850006162093Posi-Prene WhiteClinical Supply CompanyLZA2026-03-24
00850006162086Posi-Prene WhiteClinical Supply CompanyLZA2026-03-24
00850006162208Posi-ShieldClinical Supply CompanyLZA2026-03-24