FDA.report

AMMEX Professional

Primary DI
10697383974669
Brand
AMMEX Professional
Company
AMMEX CORPORATION
Model
ACNPFMP-S
Device description
master bag
Published
2023-06-16
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

Related Records

Product Codes

CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications

CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10697383974669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1069738397466910697383974669

GMDN Terms

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

Regulatory Flags

DUNS number
187070768
Device count
1
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
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 DIBrandModelCatalogPublished
00697383979414AMMEX ProfessionalACNPF491002026-01-28
00697383979421AMMEX ProfessionalACNPF491002026-01-28
108198560227631st Choice1EBNM2025-02-27
108198560227701st Choice1EBNS2025-02-27
10697383978667AMMEX ProfessionalAINPF-S2025-02-26
20697383978664AMMEX ProfessionalAINPF-S2025-02-26
008198560227421st Choice1EBNM2025-02-21
108198560227561st Choice1EBNM2025-02-21
10697383978483AMMEX ProfessionalVPF-S2024-10-21
10697383978490AMMEX ProfessionalACNPF-S2024-10-21
10697383978506GloveworksGPLHD-S2024-10-21
10697383978513AMMEX ProfessionalGPPFT-S2024-10-21
10697383978520AMMEX ProfessionalABNPF-S2024-10-21
20697383978480AMMEX ProfessionalVPF-S2024-10-21
20697383978497AMMEX ProfessionalACNPF-S2024-10-21
20697383978503GloveworksGPLHD-S2024-10-21
20697383978510AMMEX ProfessionalGPPFT-S2024-10-21
20697383978527AMMEX ProfessionalABNPF-S2024-10-21
10697383978414AMMEX ProfessionalAPFN-S2024-09-16
10697383978438GloveworksGWBEN-S2024-09-16

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