FDA.report

WellCare

Primary DI
00850048808294
Brand
WellCare
Company
Wellcare International, Inc.
Model
WBK303
Device description
WellCare 3 mil exam Black nitrile gloves, size L, 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
00850048808300PrimaryGS10
10850048808291PrimaryGS10
00850048808294Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850048808300008500488083008500488083000850048808300
1085004880829110850048808291
00850048808294008500488082948500488082940850048808294

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
00850048808317WellCareWBK3042024-02-19
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

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