FDA.reportPublic FDA data

1st Choice

Primary DI
00819856022681
Brand
1st Choice
Company
AMMEX CORPORATION
Model
1USEINL
Device description
Box
Published
2024-06-18
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211457000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211457000Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)Ammex Corporation2021-12-18LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819856022681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819856022681008198560226818198560226810819856022681

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

Regulatory Flags#

DUNS number
187070768
Device count
1
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
108198560228931st Choice1EINLC22025-11-07
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

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