FDA.report

Majestic

Primary DI
20731791133366
Brand
Majestic
Company
U. S. GLOVE CO., INC.
Model
3273BK/ 8
Device description
Disposable Nitrile Examination Gloves, Powder Free, 100/Box, Black, Size Small
Published
2022-04-20
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

Contact Domains

Product Codes

CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications

CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20731791133366PackageGS110In Commercial Distribution
00731791133362PrimaryGS10
50731791133367Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2073179113336620731791133366
00731791133362007317911333627317911333620731791133362
5073179113336750731791133367

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

Contacts

PhoneEmail
425-407-1200orders@majesticglove.com

Regulatory Flags

DUNS number
021828553
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
false
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
00731791173900MAJESTIC3277DK/ 83277DK/ 82023-01-04
00731791173917MAJESTIC3277DK/ 93277DK/ 92023-01-04
00731791173924MAJESTIC3277DK/103277DK/102023-01-04
00731791173931MAJESTIC3277DK/113277DK/112023-01-04
00731791173948MAJESTIC3277DK/123277DK/122023-01-04
00731791173955MAJESTIC3277DO/123277DO/122023-01-04
00731791173962MAJESTIC3277DO/113277DO/112023-01-04
00731791173979MAJESTIC3277DO/103277DO/102023-01-04
00731791173986MAJESTIC3277DO/ 93277DO/ 92023-01-04
00731791173993MAJESTIC3277DO/ 83277DO/ 82023-01-04
20731791030238Majestic3418/ 83418/ 82022-04-20
20731791030245Majestic3418/ 93418/ 92022-04-20
20731791030252Majestic3418/103418/102022-04-20
20731791030269Majestic3418/113418/112022-04-20
20731791030276Majestic3418/123418/122022-04-20
20731791034540Majestic3273/ 83273/ 82022-04-20
20731791034557Majestic3273/ 93273/ 92022-04-20
20731791034571Majestic3273/113273/112022-04-20
20731791034632Majestic3273/123273/122022-04-20
20731791133373Majestic3273BK/ 93273BK/ 92022-04-20

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