FDA.reportPublic FDA data

Basic

Primary DI
10810206691684
Brand
Basic
Company
BASIC MEDICAL TECHNOLOGY INC.
Model
NGPF201C6
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
Rx
false
OTC
false
Sterile
false
Single use
true

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
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
10810206691684PackageGS110In Commercial Distribution
00810206691687PrimaryGS10
01810206691686Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081020669168410810206691684
00810206691687008102066916878102066916870810206691687
01810206691686018102066916861810206691686

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
125908235
Device count
200
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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10840330706770ProCureTwin Med, LLCLZA2026-06-01
10840330706787ProCureTwin Med, LLCLZA2026-06-01