FDA.reportPublic FDA data

American Hospital Supply

Primary DI
00850054429322
Brand
American Hospital Supply
Company
American Hospital Supply LLC
Model
AHS-GN-XS_BX
Catalog number
AHS-GN-XS_BX
Device description
AHS Nitrile Gloves |Chemo-Rated | X-Small | 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
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
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
00850054429339PrimaryGS10
00850054429322Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850054429339008500544293398500544293390850054429339
00850054429322008500544293228500544293220850054429322

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
888-621-5011info@american-hospitalsupply.com

Regulatory Flags#

DUNS number
118098262
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
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
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
00810219420090American Hospital SupplyAHS-ESL_CSAHS-ESL_CS2026-03-10
00810219420113American Hospital SupplyAHS-PFS_EAAHS-PFS_EA2026-03-10
00850073571903American Hospital SupplyAHS-HOT-69_EAAHS-HOT-69_EA2026-03-10
00850073571088American Hospital SupplyAHS-ICE-69_CSAHS-ICE-69_CS2025-07-28
00850073571101American Hospital SupplyAHS-HCP-RE_PRAHS-HCP-RE_PR2025-07-28
00850073571118American Hospital SupplyAHS-HCP-RE_CSAHS-HCP-RE_CS2025-07-28
00850073571095American Hospital SupplyAHS-HCP-RE_EAAHS-HCP-RE_EA2025-07-10
00850073571071American Hospital SupplyAHS-ICE-69_EAAHS-ICE-69_EA2025-07-09
00850068404926American Hospital SupplyAHS-CS-KHB-S-3_CSAHS-CS-KHB-S-3_CS2025-07-28
00850068404957American Hospital SupplyAHS-CS-KHB-M-3_CSAHS-CS-KHB-M-3_CS2025-07-28
00850068404988American Hospital SupplyAHS-CS-KHB-L-3_CSAHS-CS-KHB-L-3_CS2025-07-28
00850073571019American Hospital SupplyAHS-CS-KHB-XL-3_CSAHS-CS-KHB-XL-3_CS2025-07-28
10850068404817American Hospital SupplyAHS-CS-KHB-S-3_CSAHS-CS-KHB-S-3_CS2025-07-28
10850068404831American Hospital SupplyAHS-CS-KHB-M-3_CSAHS-CS-KHB-M-3_CS2025-07-28
10850068404855American Hospital SupplyAHS-CS-KHB-L-3_CSAHS-CS-KHB-L-3_CS2025-07-28
10850068404879American Hospital SupplyAHS-CS-KHB-XL-3_CSAHS-CS-KHB-XL-3_CS2025-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10840330702246ProCureTwin Med, LLCLZA2026-06-01
10840330706756ProCureTwin Med, LLCLZA2026-06-01
10840330706763ProCureTwin Med, LLCLZA2026-06-01
10840330706770ProCureTwin Med, LLCLZA2026-06-01
10840330706787ProCureTwin Med, LLCLZA2026-06-01
10840330706794ProCureTwin Med, LLCLZA2026-06-01
10860015093728MaadhoMaadho Distributors Inc.LZA2026-06-01
10860015093735MaadhoMaadho Distributors Inc.LZA2026-06-01
10860015093742MaadhoMaadho Distributors Inc.LZA2026-06-01
10860015093759MaadhoMaadho Distributors Inc.LZA2026-06-01
10840330702000ProCureTwin Med, LLCLZA2026-05-29
10840330702024ProCureTwin Med, LLCLZA2026-05-29
10840330702048ProCureTwin Med, LLCLZA2026-05-29
10840330702062ProCureTwin Med, LLCLZA2026-05-29
10840330702086ProCureTwin Med, LLCLZA2026-05-29
10840330702109ProCureTwin Med, LLCLZA2026-05-29
10840330702123ProCureTwin Med, LLCLZA2026-05-29
10840330702147ProCureTwin Med, LLCLZA2026-05-29
10840330702161ProCureTwin Med, LLCLZA2026-05-29
10840330702185ProCureTwin Med, LLCLZA2026-05-29