FDA.reportPublic FDA data

RISERVA

Primary DI
G378BASVGPF40032
Brand
RISERVA
Company
Mohawk Hospital Equipment, Inc.
Model
BASVGPF40032
Catalog number
BASVGPF4003
Device description
RISERVA VINYL EXAMINATION GLOVES LARGE BOX OF 150
Published
2023-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110981000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110981000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G378BASVGPF40032PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vinyl examination/treatment glove, non-powderedA non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. 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 table
Method

Regulatory Flags#

DUNS number
013326384
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G378BASNGPF30011RISERVABASNGPF30011BASNGPF30012023-03-10
G378BASNGPF30021RISERVABASNGPF30021BASNGPF30022023-03-10
G378BASNGPF30022RISERVABASNGPF30022BASNGPF30022023-03-10
G378BASNGPF30031RISERVABASNGPF30031BASNGPF30032023-03-10
G378BASNGPF30032RISERVABASNGPF30021BASNGPF30032023-03-10
G378BASNGPF30041RISERVABASNGPF30042BASNGPF30042023-03-10
G378BASNGPF30042RISERVABASNGPF30042BASNGPF30042023-03-10
G378BASVGPF40011RISERVABASVGPF40011BASVGPF40012023-03-10
G378BASVGPF40012RISERVABASVGPF40012BASVGPF40012023-03-10
G378BASVGPF40021RISERVABASVGPF40021BASVGPF40022023-03-10
G378BASVGPF40022RISERVABASVGPF40022BASVGPF40022023-03-10
G378BASVGPF40031RISERVABASVGPF40031BASVGPF40032023-03-10
G378BASVGPF40041RISERVABASVGPF40041BASVGPF40042023-03-10
G378BASVGPF40042RISERVABASVGPF40042BASVGPF40042023-03-10
G378BASNGPF30012RISERVABASNGPF30012BASNGPF30012023-03-09

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Primary DI, Brand, Company table
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