TORQ

Primary DI
10795847979325
Brand
TORQ
Company
Imperial Bag & Paper Co. LLC
Model
HDGLOVES-XL
Published
2024-08-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K232252000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232252000Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange)Dehai (Shandong) Medical Gloves, Co., Ltd.2023-11-28LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10795847979325PrimaryGS10
00795847979328Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1079584797932510795847979325
00795847979328007958479793287958479793280795847979328

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.

Regulatory Flags#

DUNS number
137977224
Device count
10

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840064634653Victoria BayVBG2N5SB2025-07-25
10840064634660Victoria BayVBG2N5MB2025-07-25
10840064634677Victoria BayVBG2N5LB2025-07-25
10840064634684Victoria BayVBG2N5XLB2025-07-25
10840064634691Victoria BayVBG2N5SL2025-07-25
10840064634707Victoria BayVBG2N5ML2025-07-25
10840064634714Victoria BayVBG2N5LL2025-07-25
10840064634721Victoria BayVBG2N5XLL2025-07-25
00840064634656Victoria BayVBG2N5SB2025-07-25
00840064634663Victoria BayVBG2N5MB2025-07-25
00840064634670Victoria BayVBG2N5LB2025-07-25
00840064634687Victoria BayVBG2N5XLB2025-07-25
00840064634694Victoria BayVBG2N5SL2025-07-25
00840064634700Victoria BayVBG2N5ML2025-07-25
00840064634717Victoria BayVBG2N5LL2025-07-25
00840064634724Victoria BayVBG2N5XLL2025-07-25
10795847979257TORQGLOVES-L2024-08-25
10795847979264TORQGLOVES-M2024-08-25
10795847979271TORQGLOVES-S2024-08-25
10795847979288TORQGLOVES-XL2024-08-25

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