FDA.reportPublic FDA data

Patient Armor Seaprene

Primary DI
10858653006880
Brand
Patient Armor Seaprene
Company
AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.
Model
S/Case
Catalog number
PA502CS
Device description
Patient Armor Seaprene P.F Polychloroprene Exam Gloves (S) -100/Bx/10/CS
Published
2022-12-14
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
LZCPatient Examination Glove, Specialty
OPCPowder-Free Polychloroprene Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1
OPCPowder-Free Polychloroprene Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858653006880PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085865300688010858653006880

GMDN Terms#

Term, Definition table
TermDefinition
Polychloroprene examination/treatment glove, non-powderedA device made of polychloroprene (neoprene) 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/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
180611519
Device count
1
Lot or batch
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
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