FDA.reportPublic FDA data

TOUCH Chemo Tested Nitrile Exam Glove

Primary DI
00850014448226
Brand
TOUCH Chemo Tested Nitrile Exam Glove
Company
LABOTEK GROUP CORP
Model
PRG-CTN-M
Device description
TOUCH Nitrile Examination Glove, Chemotherapy tested, Size Medium
Published
2024-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
K170136000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170136000Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsShandong Feiyang Professional Gloves Co., Ltd.2017-08-25LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850014448226PackageGS1200In Commercial Distribution
10850014448223PackageGS110In Commercial Distribution
00850014448219PrimaryGS10
10850014448216Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850014448226008500144482268500144482260850014448226
1085001444822310850014448223
00850014448219008500144482198500144482190850014448219
1085001444821610850014448216

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 Temperature41 Degrees Fahrenheit100 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7877851555e.colon@labotekgroup.com

Regulatory Flags#

DUNS number
117338398
Device count
200
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
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014448424VacSure EZ Care Pressure Activate Safety LancetVEZC-30152024-12-03
00850014448431VacSure EZ Care Pressure Activate Safety LancetVEZC-30152024-12-03
00850014448462VacSure EZ Care Pressure Activate Safety LancetVEZC-21222024-12-03
00850014448332VACSURE Disposable TourniquetsVS-DTD2024-03-18
00850014448134VACSURE Uni-BandRR-1512024-03-18
00850014448158Labotek Spot BandageRR-1502024-03-18
00850014448172TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-XS2024-03-18
00850014448196TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-S2024-03-18
00850014448219TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-M2024-03-18
00850014448233TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-L2024-03-18
00850014448257TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-XL2024-03-18
00850014448349VACSURE Sharp ContainerRRI-1QT2024-03-18
00850014448356VACSURE Sharp ContainerRRI-5QT2024-03-18
00850014448363VACSURE Sharp ContainerRRI-2GAL2024-03-18
00850014448370VACSURE Sharp ContainerRRI-3GAL-S2024-03-18
00850014448387VACSURE Sharp ContainerRRI-8GAL2024-03-18
00850014448141VACSURE Uni-BandRR-1512024-03-18
00850014448165Labotek Spot BandageRR-1502024-03-18
00850014448189TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-XS2024-03-18
00850014448202TOUCH Chemo Tested Nitrile Exam GlovePRG-CTN-S2024-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850069531195Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531201Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531218Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531225Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531232Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531249Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
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
00199972000764CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00850069531010Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531027Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531034Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531041Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531058Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15