FDA.reportPublic FDA data

American Health and Safety

Primary DI
20850020922592
Brand
American Health and Safety
Company
Labsource, Inc.
Model
GN620-4
Catalog number
GN620-4
Device description
American Health and Safety™ Zircon™ EX Blue Disposable Nitrile Exam Grade Gloves, X-Large, Case of 10 Packs
Published
2023-08-16
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
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222815000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222815000Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and FentanylZibo Lanhua Medical Packaging Material Co., Ltd.2022-12-04LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850020922592PackageGS110In Commercial Distribution
10850020922595PrimaryGS10
00850020922598Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085002092259220850020922592
1085002092259510850020922595
00850020922598008500209225988500209225980850020922598

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
6303431740sbany@labsource.com

Regulatory Flags#

DUNS number
199668690
Device count
100
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850020922984American Health and SafetyGN760-1GN760-12025-03-27
10850061371000American Health and SafetyGN760-2GN760-22025-03-27
10850061371017American Health and SafetyGN760-3GN760-32025-03-27
10850061371024American Health and SafetyGN760-4GN760-42025-03-27
10850061371031American Health and SafetyGN760-5GN760-52025-03-27
10850061371208American Health and Safety GL150-1GL150-12025-03-27
10850061371215American Health and Safety GL150-2GL150-22025-03-27
10850061371222American Health and Safety GL150-3GL150-32025-03-27
10850061371239American Health and Safety GL150-4GL150-42025-03-27
20850020922981American Health and SafetyGN760-1GN760-12025-03-27
20850061371007American Health and SafetyGN760-2GN760-22025-03-27
20850061371014American Health and SafetyGN760-3GN760-32025-03-27
20850061371021American Health and SafetyGN760-4GN760-42025-03-27
20850061371038American Health and SafetyGN760-5GN760-52025-03-27
20850061371205American Health and Safety GL150-1GL150-12025-03-27
20850061371212American Health and Safety GL150-2GL150-22025-03-27
20850061371229American Health and Safety GL150-3GL150-32025-03-27
20850061371236American Health and Safety GL150-4GL150-42025-03-27
10850020922410American Health and SafetyGN290-1GN290-12024-12-13
10850020922427American Health and SafetyGN290-2GN290-22024-12-13

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Primary DI, Brand, Company table
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