FDA.reportPublic FDA data

American Health and Safety

Primary DI
20850061371038
Brand
American Health and Safety
Company
Labsource, Inc.
Model
GN760-5
Catalog number
GN760-5
Device description
American Health and Safety™ Zircon™ X Orange Disposable Nitrile Exam Grade Gloves,2X-Large
Published
2025-03-27
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
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850061371038PackageGS110In Commercial Distribution
10850061371031PrimaryGS10
00850061371034Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085006137103820850061371038
1085006137103110850061371031
00850061371034008500613710348500613710340850061371034

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
630-343-1700Sbany@labsource.com

Regulatory Flags#

DUNS number
199668690
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
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
10850061371246American Health and SafetyGN370-0GN370-02026-11-02
10850061371260American Health and SafetyGN370-1GN370-12026-11-02
10850061371284American Health and SafetyGN370-2GN370-22026-11-02
10850061371291American Health and SafetyGN370-3GN370-32026-11-02
10850061371307American Health and SafetyGN370-4GN370-42026-11-02
10850061371314American Health and SafetyGN370-5GN370-52026-11-02
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
20850061371205American Health and Safety GL150-1GL150-12025-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850061371246American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371260American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371284American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371291American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371307American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371314American Health and SafetyLabsource, Inc.QDO2026-11-02
00724312268568VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724351992639VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724351992646VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00850069531195Maxter BlackMaxter Healthcare IncorporatedQDO2026-10-16
00850069531201Maxter BlackMaxter Healthcare IncorporatedQDO2026-10-16
00850069531218Maxter BlackMaxter Healthcare IncorporatedQDO2026-10-16
00850069531225Maxter BlackMaxter Healthcare IncorporatedQDO2026-10-16
00850069531232Maxter BlackMaxter Healthcare IncorporatedQDO2026-10-16
00850069531249Maxter BlackMaxter Healthcare IncorporatedQDO2026-10-16
00199972000641CuraplexBOUND TREE MEDICAL, LLCQDO2026-10-15
00199972000672CuraplexBOUND TREE MEDICAL, LLCQDO2026-10-15
00199972000702CuraplexBOUND TREE MEDICAL, LLCQDO2026-10-15
00199972000733CuraplexBOUND TREE MEDICAL, LLCQDO2026-10-15
00199972000764CuraplexBOUND TREE MEDICAL, LLCQDO2026-10-15
00850069531010Elevate BluMaxter Healthcare IncorporatedQDO2026-10-15
00850069531027Elevate BluMaxter Healthcare IncorporatedQDO2026-10-15
00850069531034Elevate BluMaxter Healthcare IncorporatedQDO2026-10-15
00850069531041Elevate BluMaxter Healthcare IncorporatedQDO2026-10-15
00850069531058Elevate BluMaxter Healthcare IncorporatedQDO2026-10-15
00850069531065Elevate BluMaxter Healthcare IncorporatedQDO2026-10-15
00850069531133Maxter BlueMaxter Healthcare IncorporatedQDO2026-10-15
00850069531140Maxter BlueMaxter Healthcare IncorporatedQDO2026-10-15