FDA.reportPublic FDA data

TORQ

Primary DI
10795847979264
Brand
TORQ
Company
Imperial Bag & Paper Co. LLC
Model
GLOVES-M
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
K123869000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123869000POWDER-FREE NITRILE PATIENT EXAMINATION GLOVESDehai (Shandong) Medical Gloves, Co., Ltd.2013-02-28LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10795847979264PrimaryGS10
00795847979267Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1079584797926410795847979264
00795847979267007958479792677958479792670795847979267

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
10840064641262Victoria BayVBG2N4SB2026-08-03
10840064641279Victoria BayVBG2N4MB2026-08-03
10840064641286Victoria BayVBG2N4LB2026-08-03
10840064641293Victoria BayVBG2N4XLB2026-08-03
10840064641309Victoria BayVBG2N4XXLB2026-08-03
10840064641316Victoria BayVBG2N4SL2026-08-03
10840064641323Victoria BayVBG2N4ML2026-08-03
10840064641330Victoria BayVBG2N4LL2026-08-03
10840064641347Victoria BayVBG2N4XLL2026-08-03
10840064641354Victoria BayVBG2N4XXLL2026-08-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850054870551BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870568BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870575BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870582BAYLAB USABaylab USA, LLCLZA2026-10-01
00662956201063Body Guard[Fastenal CompanyLZA2026-09-30
00662956201285Body Guard[Fastenal CompanyLZA2026-09-30
00662956202558Body GuardFastenal CompanyLZA2026-09-30
00662956203258Body GuardFastenal CompanyLZA2026-09-30
00662956203661BodyguardFastenal CompanyLZA2026-09-30
00662956203760BodyguardFastenal CompanyLZA2026-09-30
00662956205320Body GuardFastenal CompanyLZA2026-09-30
00662956210171Body GuardFastenal CompanyLZA2026-09-30
10860015093766MaadhoMaadho Distributors Inc.LZA2026-09-24
10860015093773MaadhoMaadho Distributors Inc.LZA2026-09-24
10860015093780MaadhoMaadho Distributors Inc.LZA2026-09-24
00199536900219BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900226BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900233BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900240BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900257BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900820BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900837BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900844BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900851BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00811114033026TopGripUnisafe Inc.LZA2026-08-14
00850016052001NiTouchKasa Trading, LLCLZA2026-08-03
00850016052025NiTouchKasa Trading, LLCLZA2026-08-03
00850016052049NiTouchKasa Trading, LLCLZA2026-08-03
00850016052056NiTouchKasa Trading, LLCLZA2026-08-03