FDA.reportPublic FDA data

Patient Armor Nitrile Black

Primary DI
00858653006739
Brand
Patient Armor Nitrile Black
Company
AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.
Model
L
Catalog number
PA204
Device description
Patient Armor BLACK PF Nitrile Exam Gloves (L) - 100/Bx
Published
2024-02-19
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
LZCMedical Glove, Specialty
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858653006739PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858653006739008586530067398586530067390858653006739

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
180611519
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850048528987Amtouch Etchant Gel1.2ml (4 pack)AMETCH42024-05-15
00850048528994Amtouch Etchant Gel1.2ml (24 pack)AMETCH242024-05-15
00850058951003Amtouch Etchant GelJumbo Kit 25mlAMETCHJUMBO-KIT2024-05-15
00850058951010Amtouch Etchant GelJumbo Refill 25mlAMETCHJUMBO2024-05-15
00850048528338EvolusSSunsc3022023-07-03
00850048528352EvolusLSunsc3042023-07-03
00850048528345EvolusMSunsc3032023-07-03
10810109910356EvolusS/CaseSunsc302CS2023-07-03
10810109910363EvolusM/CaseSunsc303CS2023-07-03
10810109910370EvolusL/CaseSunsc304CS2023-07-03
00850058951232Amtouch ToothbrushesPrepasted - AdultAMTB-PP2024-10-17
00850058951249Amtouch Dental KitDental Hygiene Kit (5pc)AMDHK2024-10-17
00850058951256Amtouch Orthodontic KitOrthodontic Kit (8pc)AMOHK-AD2024-10-17
00850058951355Amtouch Orthodontic FlosspicksUnscented - WhiteAMOFP2024-10-17
00850048528925Amtouch Temporary Crown & Bridge MaterialA2AMTCBA22024-05-14
00850048528932Amtouch Temporary Crown & Bridge MaterialA1AMTCBA12024-05-14
00850048528864Amtouch Air/Water Syringe TipsMetal Core/White Tube - 250/BagAM001AW-WH2024-10-08
00850048528901Amtouch Air/Water Syringe TipsColor Core/Clear Tube - 250/BagAM001AW2024-10-08
00850048528918Amtouch Air/Water Syringe TipsColor Core/Clear Tube - 1000/BagAM001AW-10002024-10-08
00850058951263Amtouch Intraoral TipsYellowAM-001IOYE2024-10-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197344133898MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
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.QDO2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500674HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500681HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500698HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500704HalyardO&M HALYARD, INC.QDO2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500711HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502388HalyardO&M HALYARD, INC.QDO2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.QDO2026-06-04