FDA.reportPublic FDA data

Purpose Select

Primary DI
00850050195092
Brand
Purpose Select
Company
Purpose Veterinary Supply LLC
Model
L-BLU-300
Published
2023-05-01
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
K001619000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001619000MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE)Multisafe Sdn. Bhd.2000-07-26LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850050195092PrimaryGS10
10850050195099Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850050195092008500501950928500501950920850050195092
1085005019509910850050195099

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.

Regulatory Flags#

DUNS number
118923926
Device count
300
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850050195016Purpose Select XS-BLU-1002023-05-01
00850050195023Purpose Select S-BLU-1002023-05-01
00850050195030Purpose Select M-BLU-1002023-05-01
00850050195047Purpose Select L-BLU-1002023-05-01
00850050195054Purpose Select XL-BLU-1002023-05-01
00850050195061Purpose Select XS-BLU-3002023-05-01
00850050195078Purpose Select S-BLU-3002023-05-01
00850050195085Purpose Select M-BLU-3002023-05-01
00850050195108Purpose Select XL-BLU-2502023-05-01
00850050195115Purpose Select XS-BLK-3002023-05-01
00850050195122Purpose Select S-BLK-3.002023-05-01
00850050195139Purpose Select M-BLK-3002023-05-01
00850050195146Purpose Select L-BLK-3002023-05-01
00850050195153Purpose Select XL-BLK-2502023-05-01
10850050195013Purpose Select XS-BLU-1002023-05-01
10850050195020Purpose Select S-BLU-1002023-05-01
10850050195037Purpose Select M-BLU-1002023-05-01
10850050195044Purpose Select L-BLU-1002023-05-01
10850050195051Purpose Select XL-BLU-1002023-05-01
10850050195068Purpose Select XS-BLU-3002023-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00726893120754TrustexGLOBAL PROTECTION CORP.LZA2026-06-04
08859826311003LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826312000LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826313007LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
08859826314004LYDUSNATHARN TRADING COMPANY LIMITEDLZA2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZA2026-06-04
00194346693122EquateWAL-MART STORES, INC.LZA2026-06-02
00194346693139EquateWAL-MART STORES, INC.LZA2026-06-02
00768627017282Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017299Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017305Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017312Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
10840330702208ProCureTwin Med, LLCLZA2026-06-01
10840330702215ProCureTwin Med, LLCLZA2026-06-01
10840330702222ProCureTwin Med, LLCLZA2026-06-01
10840330702239ProCureTwin Med, LLCLZA2026-06-01
10840330702246ProCureTwin Med, LLCLZA2026-06-01
10840330706756ProCureTwin Med, LLCLZA2026-06-01
10840330706763ProCureTwin Med, LLCLZA2026-06-01
10840330706770ProCureTwin Med, LLCLZA2026-06-01
10840330706787ProCureTwin Med, LLCLZA2026-06-01