FDA.reportPublic FDA data

Diska Nulife

Primary DI
00810115891123
Brand
Diska Nulife
Company
Diska LLC
Model
DNL-NG-BK-L
Device description
Black Nitrile gloves - Single box(Large)
Published
2023-06-19
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

Contact Domains#

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
K133307000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133307000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810115891123PackageGS110In Commercial Distribution
00810115891116PrimaryGS10
00810115891109Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810115891123008101158911238101158911230810115891123
00810115891116008101158911168101158911160810115891116
00810115891109008101158911098101158911090810115891109

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
201-675-6037ashish.bharal@diskatech.com

Regulatory Flags#

DUNS number
006311259
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810115891581Diska NulifeDNL-TMB-2282-G2023-08-25
00810115891697Diska NulifeDNL-TTS012023-08-25
00810115892328Diska NulifeDNL-TMB2084-A2023-10-20
00810115892342Diska NuLifeVGM04(Ref. DNL-VGM04)2023-10-05
00810115892427Diska NuLifeVGS01 (REF: DNL-VGS01)2023-10-05
00810115892335Diska NulifeDNL-TMB2084-A2023-10-20
00810115892366Diska NuLifeDNL-GBS-2012-B2023-10-05
00810115892380Diska NuLifeDNL-YM4022023-10-05
00810115892458Diska NuLifeDNL-VGC012023-10-05
00810115892359Diska NuLifeVGM04(Ref. DNL-VGM04)2023-10-05
00810115892373Diska NuLifeDNL-GBS-2012-B2023-10-05
00810115892403Diska NuLifeDNL-YM4022023-10-05
00810115892441Diska NuLifeVGS01 (REF: DNL-VGS01)2023-10-05
00810115892465Diska NuLifeDNL-VGC012023-10-05
00810115891642Diska NulifeHH-XIII-T2023-08-25
00810115891666Diska NulifeTCS012023-08-25
00810115891710Diska NulifeI2023-08-25
00810115891598Diska NulifeDNL-TMB-2282-G2023-08-25
00810115891659Diska NulifeHH-XIII-T2023-08-25
00810115891673Diska NulifeTCS012023-08-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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D184MYNTGNLG100BLK14MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNLG100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNLG100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100BLK13MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXL100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXL100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100PNK1MYNTMynt ProfessionalLZA2026-10-16
00199972000641CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000672CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000702CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000733CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
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00850069531010Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531027Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531034Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531041Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
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