FDA.reportPublic FDA data

NWCS Medical Divison ArmorGuard

Primary DI
00860010386422
Brand
NWCS Medical Divison ArmorGuard
Company
New Wave Cleaning Solutions LLC
Model
NG-BLUE-MED
Published
2023-05-19
Public version status
Update
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
K112294000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112294000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010386453PackageGS110In Commercial Distribution
00860010386422PrimaryGS10
10860010386429Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010386453008600103864538600103864530860010386453
00860010386422008600103864228600103864220860010386422
1086001038642910860010386429

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
047495265
Device count
100

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010386408NWCS Medical Divison ArmorGuardNG_BLUE-XL2023-05-19
00860010386415NWCS Medical Divison ArmorGuardNG-BLUE-LG2023-05-19
00860010386439NWCS Medical Divison ArmorGuardNG-BLUE-SM2023-05-19
00860010386477NWCS Medical Divison ArmorGuardNG_BLUE-XL2023-05-19
00860010386460NWCS Medical Divison ArmorGuardNG-BLUE-LG2023-05-19
00860010386453NWCS Medical Divison ArmorGuardNG-BLUE-MED2023-05-19
00860010386446NWCS Medical Divison ArmorGuardNG-BLUE-SM2023-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10840330706794ProCureTwin Med, LLCLZA2026-06-01
10860015093728MaadhoMaadho Distributors Inc.LZA2026-06-01
10860015093735MaadhoMaadho Distributors Inc.LZA2026-06-01
10860015093742MaadhoMaadho Distributors Inc.LZA2026-06-01
10860015093759MaadhoMaadho Distributors Inc.LZA2026-06-01
10840330702000ProCureTwin Med, LLCLZA2026-05-29
10840330702024ProCureTwin Med, LLCLZA2026-05-29
10840330702048ProCureTwin Med, LLCLZA2026-05-29
10840330702062ProCureTwin Med, LLCLZA2026-05-29
10840330702086ProCureTwin Med, LLCLZA2026-05-29
10840330702109ProCureTwin Med, LLCLZA2026-05-29
10840330702123ProCureTwin Med, LLCLZA2026-05-29
10840330702147ProCureTwin Med, LLCLZA2026-05-29
10840330702161ProCureTwin Med, LLCLZA2026-05-29
10840330702185ProCureTwin Med, LLCLZA2026-05-29