FDA.reportPublic FDA data

LUXSPA Large nitrile disposable exam gloves

Primary DI
10860009297767
Brand
LUXSPA Large nitrile disposable exam gloves
Company
Beltway Nail Supply, LLC
Model
0005
Device description
Size Large. Case of 10 boxes. Single use nitrile disposable exam gloves.
Published
2022-11-21
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
10860009297767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1086000929776710860009297767

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit100 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
068047800
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009297708LUXSPA Extra Small nitrile disposable exam gloves00042022-11-21
00860009297722LUXSPA Small nitrile disposable exam gloves00032022-11-21
00860009297746LUXSPA Medium nitrile disposable exam gloves00022022-11-21
00860009297760LUXSPA Large nitrile disposable exam gloves00012022-11-21
10860009297705LUXSPA Extra Small nitrile disposable exam gloves00082022-11-21
10860009297729LUXSPA Small nitrile disposable exam gloves00072022-11-21
10860009297743LUXSPA Medium nitrile disposable exam gloves00062022-11-21

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Primary DI, Brand, Company table
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