FDA.reportPublic FDA data

Majestic

Primary DI
00731791034546
Brand
Majestic
Company
U. S. GLOVE CO., INC.
Model
3273/ 8
Catalog number
3273/ 8
Device description
Disposable Nitrile Examination Gloves, Powder Free, 100/Box, Size Small
Published
2022-04-20
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
20731791034540PackageGS110In Commercial Distribution
00731791034546PrimaryGS10
50731791034541Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2073179103454020731791034540
00731791034546007317910345467317910345460731791034546
5073179103454150731791034541

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.

Contacts#

Phone, Email table
PhoneEmail
425-407-1200orders@majesticglove.com

Regulatory Flags#

DUNS number
021828553
Device count
100
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
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
00731791030234Majestic3418/ 83418/ 82022-04-20
00731791030241Majestic3418/ 93418/ 92022-04-20
00731791030258Majestic3418/103418/102022-04-20
00731791030265Majestic3418/113418/112022-04-20
00731791030272Majestic3418/123418/122022-04-20
00731791034553Majestic3273/ 93273/ 92022-04-20
00731791034577Majestic3273/113273/112022-04-20
00731791034638Majestic3273/123273/122022-04-20
00731791133362Majestic3273BK/ 82022-04-20
00731791133379Majestic3273BK/ 93273BK/ 92022-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08859185202172mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202189mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202196mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202202mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202219mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209249Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209256Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209263Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209270Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209287Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209294Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209300Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209317Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209324Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209331Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
09551006060525NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060532NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060549NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060556NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060563NITRILECARE PREMIUMCAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060624NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060631NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060648NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060655NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060662NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060822NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061225NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061249CHLOROPRENE EXAMINATION PF CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061256CHLOROPRENE EXAMINATION PF CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061263CHLOROPRENE EXAMINATION PF CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08