FDA.reportPublic FDA data

NWCS Medical Divison ArmorGuard

Primary DI
00860010386460
Brand
NWCS Medical Divison ArmorGuard
Company
New Wave Cleaning Solutions LLC
Model
NG-BLUE-LG
Published
2023-05-19
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

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
00860010386460PackageGS110In Commercial Distribution
00860010386415PrimaryGS10
10860010386412Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010386460008600103864608600103864600860010386460
00860010386415008600103864158600103864150860010386415
1086001038641210860010386412

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

Regulatory Flags#

DUNS number
047495265
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
true
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
00860010386408NWCS Medical Divison ArmorGuardNG_BLUE-XL2023-05-19
00860010386415NWCS Medical Divison ArmorGuardNG-BLUE-LG2023-05-19
00860010386422NWCS Medical Divison ArmorGuardNG-BLUE-MED2023-05-19
00860010386439NWCS Medical Divison ArmorGuardNG-BLUE-SM2023-05-19
00860010386477NWCS Medical Divison ArmorGuardNG_BLUE-XL2023-05-19
00860010386453NWCS Medical Divison ArmorGuardNG-BLUE-MED2023-05-19
00860010386446NWCS Medical Divison ArmorGuardNG-BLUE-SM2023-05-19

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Primary DI, Brand, Company table
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