FDA.reportPublic FDA data

Basic

Primary DI
00810206691700
Brand
Basic
Company
BASIC MEDICAL TECHNOLOGY INC.
Model
NGPF201C8
Device description
Synguard Nitrile Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Published
2026-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove
LZCMedical Glove, Specialty
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243441000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243441000Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue)Basic Medical Technology, Inc.2025-01-31LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810206691707PackageGS110In Commercial Distribution
00810206691700PrimaryGS10
01810206691709Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081020669170710810206691707
00810206691700008102066917008102066917000810206691700
01810206691709018102066917091810206691709

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
125908235
Device count
180

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810206690956BasicSGBE80022026-02-13
00810206690963BasicSGBE80032026-02-13
00810206690970BasicSGBE80042026-02-13
00810206691151BasicBMPF20142026-02-13
00810206691168BasicBMPF20152026-02-13
00810206691175BasicBMPF20162026-02-13
00810206691182BasicBMPF20172026-02-13
00810206691533BasicANBM200132026-02-13
00810206691557BasicANBM200152026-02-13
00810206691564BasicANBM200162026-02-13
00810206691571BasicANBM200172026-02-13
00810206691588BasicANBM200182026-02-13
00810206691595BasicSMPF30002026-02-13
00810206691601BasicSMPF30012026-02-13
00810206691618BasicSMPF30022026-02-13
00810206691625BasicSMPF30032026-02-13
00810206691632BasicSMPF30042026-02-13
00810206691649BasicSMPF30052026-02-13
00810206691656BasicNGPF201C32026-02-13
00810206691663BasicNGPF201C42026-02-13

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Primary DI, Brand, Company table
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00850016052018NiTouchKasa Trading, LLCLZA2026-08-02
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