FDA.reportPublic FDA data

American Hospital Supply

Primary DI
00850046814822
Brand
American Hospital Supply
Company
American Hospital Supply LLC
Model
AHS-GN-M_CS
Catalog number
AHS-GN-M_CS
Device description
AHS Nitrile Gloves | Chemo-Rated | Medium | Case of 1000
Published
2023-05-30
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

Contact Domains#

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
K121992000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112294000
K121992000POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORXinwei (Shandong) Plastic and Rubber Products Co.,2012-10-16LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850046814693PrimaryGS10
00850046814822Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850046814693008500468146938500468146930850046814693
00850046814822008500468148228500468148220850046814822

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

Contacts#

Phone, Email table
PhoneEmail
888-621-5044info@american-hospitalsupply.com

Regulatory Flags#

DUNS number
118098262
Device count
1000
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
false
Expiration date on label
false
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
00810219420014American Hospital SupplyAHS-ESF_EAAHS-ESF_EA2026-06-09
00810219420038American Hospital SupplyAHS-ESA_EAAHS-ESA_EA2026-06-09
00810219420052American Hospital SupplyAHS-ESA_BXAHS-ESA_BX2026-06-09
00810219420069American Hospital SupplyAHS-ESA_CSAHS-ESA_CS2026-06-09
00810219420076American Hospital SupplyAHS-ESF_BXAHS-ESF_BX2026-06-09
00810219420083American Hospital SupplyAHS-ESF_CSAHS-ESF_CS2026-06-09
00850073571385American Hospital SupplyAHS-CS-KHBE-S-3_PKAHS-CS-KHBE-S-3_PK2026-06-09
00850073571392American Hospital SupplyAHS-CS-KHBE-S-3_CSAHS-CS-KHBE-S-3_CS2026-06-09
00850073571415American Hospital SupplyAHS-CS-KHBE-M-3_PKAHS-CS-KHBE-M-3_PK2026-06-09
00850073571422American Hospital SupplyAHS-CS-KHBE-M-3_CSAHS-CS-KHBE-M-3_CS2026-06-09
00850073571446American Hospital SupplyAHS-CS-KHBE-L-3_PKAHS-CS-KHBE-L-3_PK2026-06-09
00850073571453American Hospital SupplyAHS-CS-KHBE-L-3_CSAHS-CS-KHBE-L-3_CS2026-06-09
00850073571477American Hospital SupplyAHS-CS-KHBE-XL-3_PKAHS-CS-KHBE-XL-3_PK2026-06-09
00850073571484American Hospital SupplyAHS-CS-KHBE-XL-3_CSAHS-CS-KHBE-XL-3_CS2026-06-09
00850073571996American Hospital SupplyAHS-ESL_EAAHS-ESL_EA2026-06-09
00810219420090American Hospital SupplyAHS-ESL_BXAHS-ESL_BX2026-06-09
10810219420158American Hospital SupplyAHS-ES-1_BXAHS-ES-1_BX2026-04-27
00810219420137American Hospital SupplyAHS-PFS_CSAHS-PFS_CS2026-03-11
00810219420120American Hospital SupplyAHS-PFS_CSAHS-PFS_CS2026-03-11
00810219420106American Hospital SupplyAHS-ESL_CSAHS-ESL_CS2026-03-10

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Primary DI, Brand, Company table
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00724351992639VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992646VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
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00755676002796mvetADI MedicalLZA2026-10-23
00755676002826mvetADI MedicalLZA2026-10-23
00755676002857mvetADI MedicalLZA2026-10-23
00755676002994mvetADI MedicalLZA2026-10-23
00755676003021mvetADI MedicalLZA2026-10-23
00755676003052mvetADI MedicalLZA2026-10-23
00755676003083mvetADI MedicalLZA2026-10-23
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00850069531201Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
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00850069531232Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
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D184MYNTGNLG100BLK14MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNLG100BLU1MYNTMynt ProfessionalLZA2026-10-16
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D184MYNTGNME100BLK13MYNTMynt ProfessionalLZA2026-10-16
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D184MYNTGNSM100BLK1MYNTMynt ProfessionalLZA2026-10-16