FDA.reportPublic FDA data

1st Choice

Primary DI
10819856022893
Brand
1st Choice
Company
AMMEX CORPORATION
Model
1EINLC2
Device description
1st Choice
Published
2025-11-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove
LZCMedical Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10819856022893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081985602289310819856022893

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.

Regulatory Flags#

DUNS number
187070768
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10697383979435GloveworksGPNHD-S2026-07-10
20697383979432GloveworksGPNHD-S2026-07-10
108198560228791st Choice1EINSC22025-11-07
108198560228861st Choice1EINMC22025-11-07
108198560229091st Choice1EINXLC22025-11-07
10697383978506GloveworksGPLHD-S2024-10-21
20697383978503GloveworksGPLHD-S2024-10-21
10697383978438GloveworksGWBEN-S2024-09-16
20697383978435GloveworksGWBEN-S2024-09-16
008198560209151st Choice1EINSP702023-07-06
008198560209221st Choice1EINMP702023-07-06
008198560209391st Choice1EINLP702023-07-06
008198560209461st Choice1EINXLP702023-07-06
008198560213181st Choice1EINSBX22023-07-06
008198560213251st Choice1EINMBX22023-07-06
008198560213321st Choice1EINLBX22023-07-06
008198560213491st Choice1EINXLBX22023-07-06
008198560225061st Choice, AMMEX Professional1EINVPFSBX22023-07-06
008198560225131st Choice, AMMEX Professional1EINVPFMBX22023-07-06
008198560225201st Choice, AMMEX Professional1EINVPFLBX22023-07-06

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850016052056NiTouchKasa Trading, LLCLZA2026-08-03
10840064641262Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
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10840064641293Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
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10840064641323Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641330Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641347Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
10840064641354Victoria BayImperial Bag & Paper Co. LLCLZA2026-08-03
00850016052018NiTouchKasa Trading, LLCLZA2026-08-02
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00199536000049BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
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00199536000056BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
00199536000056BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
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00366975065513Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065520Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00366975065537Natural ExtensionsBENCO DENTAL SUPPLY CO.LZA2026-07-30
00860010400906LuvatekR&C Imports LLCLZA2026-07-29