FDA.reportPublic FDA data

First Aid Only

Primary DI
00738743212267
Brand
First Aid Only
Company
Acme United Corporation
Model
21-226
Catalog number
21-226
Device description
Nitrile exam gloves, Large 10/box
Published
2022-01-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00738743212267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00738743212267007387432122677387432122670738743212267

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
800-835-2263customerservice@acmeunited.com

Regulatory Flags#

DUNS number
001180207
Device count
1
Premarket exempt
true
Combination product
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00092265917841First Aid Only917842026-04-23
00738743007139First Aid Only3606493606492022-01-10
00092265001472First Aid OnlyAN147AN1472021-08-10
00092265313179First Aid OnlyFAE-3131FAE-31312021-08-10
00073577900998First Aid Only90099-00290099-0022020-10-02
00092265100977First Aid Only10097100972020-10-02
00738743080309First Aid Only803080302020-12-11
00092265716086First Aid Only7116087116082020-10-06
00092265960021First Aid Only96002960022025-09-30
00092265508391First Aid OnlyM5083M50832022-01-21
00092265508490First Aid OnlyM5084M50842022-01-21
00092265508599First Aid OnlyM5085M50852022-01-21
00092265508698First Aid OnlyM5086M50862022-01-21
00092265508797First Aid OnlyM5087M50872022-01-21
00092265508896First Aid OnlyM5088M50882022-01-21
00738743210119First Aid Only21-01121-0112022-12-15
00092265022040First Aid OnlyB204B2042021-07-15
00738743961424Elite First Aid96142961422025-06-12
00738743961431Elite First Aid96143961432025-06-12
00092265002066First Aid OnlyAN206AN2062021-08-11

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