FDA.reportPublic FDA data

American Hospital Supply

Primary DI
00850054429360
Brand
American Hospital Supply
Company
American Hospital Supply LLC
Model
AHS-GN-XXL_BX
Catalog number
AHS-GN-XXL_BX
Device description
AHS Nitrile Gloves Chemo-Rated XX-Large Box of 100
Published
2024-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K121992000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
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
00850054429360PrimaryGS10
00850054429964Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850054429360008500544293608500544293600850054429360
00850054429964008500544299648500544299640850054429964

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.

Contacts#

Phone, Email table
PhoneEmail
888-621-5011info@american-hospitalsupply.com

Regulatory Flags#

DUNS number
118098262
Device count
100
Lot or batch
true

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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00197344133812MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133836MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133850MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133874MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
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.LZA2026-06-04
20680651500681HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500698HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZA2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502395HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502401HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502418HalyardO&M HALYARD, INC.LZA2026-06-04
20680651502425HalyardO&M HALYARD, INC.LZA2026-06-04
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