FDA.reportPublic FDA data

microdot® Pro Gloves

Primary DI
00847713000930
Brand
microdot® Pro Gloves
Company
Cambridge Sensors USA LLC
Model
1401-10
Device description
Microdot® Pro Nitrile Small Gloves
Published
2025-02-18
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
DQOCatheter, Intravascular, Diagnostic
LZAPolymer Patient Examination Glove
LZCMedical Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222376000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222376000Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)Shandong Lianfa Medical Plastic Products Co. , Ltd.2022-10-03FMK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847713000985PackageGS110In Commercial Distribution
00847713000930PrimaryGS10
00847713000886Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847713000985008477130009858477130009850847713000985
00847713000930008477130009308477130009300847713000930
00847713000886008477130008868477130008860847713000886

GMDN Terms#

Term, Definition table
TermDefinition
Vinyl examination/treatment glove, non-powderedA non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. 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
962314360
Device count
100
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847713001296microdot® Flex1501-102025-12-12
00847713001302microdot® Flex1502-102025-12-12
00847713001319microdot® Flex1503-102025-12-12
00847713001326microdot® Flex1504-102025-12-12
00847713001425microdot® Flex Black1601-102025-12-12
00847713001432microdot® Flex Black1602-102025-12-12
00847713001449microdot® Flex Black1603-102025-12-12
00847713001456microdot® Flex Black1604-102025-12-12
00847713001340microdot® Flex1501-102025-12-12
00847713001258microdot® Flex1502-102025-12-12
00847713001364microdot® Flex1503-102025-12-12
00847713001371microdot® Flex1504-102025-12-12
00847713001463microdot® Flex Black1601-102025-12-12
00847713001470microdot® Flex Black1602-102025-12-12
00847713001487microdot® Flex Black1603-102025-12-12
00847713001494microdot® Flex Black1604-102025-12-12
00847713000947microdot® Pro Gloves1402-102025-02-18
00847713000954microdot® Pro Gloves1403-102025-02-18
00847713000961microdot® Pro Gloves1404-102025-02-18
00847713000978microdot® Pro Gloves1405-102025-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197344133874MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00197344133898MEDLINEMEDLINE INDUSTRIES, INC.LZA2026-06-09
00818634025487Bosma EnterprisesBosma EnterprisesLZC2025-08-25
00818634025487Bosma EnterprisesBosma EnterprisesLZA2025-08-25
00080196334264MEDLINEMEDLINE INDUSTRIES, INC.LZA2025-07-17
00080196549422MEDLINEMEDLINE INDUSTRIES, INC.LZA2025-05-06
00888277415075MEDLINEMEDLINE INDUSTRIES, INC.LZA2025-05-06
00842429108574BOBBY/SOFIA KitMicrovention, Inc.DQO2025-04-30
00888277327552MEDLINEMEDLINE INDUSTRIES, INC.LZA2025-03-25
00888277327569MEDLINEMEDLINE INDUSTRIES, INC.LZA2025-03-25
00888277327576MEDLINEMEDLINE INDUSTRIES, INC.LZA2025-03-25
00197344036564MEDLINEMEDLINE INDUSTRIES, INC.LZA2024-12-12
00197344036618MEDLINEMEDLINE INDUSTRIES, INC.LZA2024-12-12
00197344036625MEDLINEMEDLINE INDUSTRIES, INC.LZA2024-12-12
00197344036632MEDLINEMEDLINE INDUSTRIES, INC.LZA2024-12-12
00197344036649MEDLINEMEDLINE INDUSTRIES, INC.LZA2024-12-12
00842429108444SofiaMicrovention, Inc.DQO2024-10-18
00842429108451SofiaMicrovention, Inc.DQO2024-10-18
00842429108468SofiaMicrovention, Inc.DQO2024-10-18
00080196009919MEDLINEMEDLINE INDUSTRIES, INC.LZA2024-08-22
00197344098135MEDLINEMEDLINE INDUSTRIES, INC.LZA2024-08-02
00888277139797MEDLINEMEDLINE INDUSTRIES, INC.LZA2024-07-12
00847212008444Elara BrandsElara Foodservice Disposables LLCLZC2024-05-14
00847212008444Elara BrandsElara Foodservice Disposables LLCLZA2024-05-14
00847212008451Elara BrandsElara Foodservice Disposables LLCLZA2024-05-14
00847212008451Elara BrandsElara Foodservice Disposables LLCLZC2024-05-14
00847212008468Elara BrandsElara Foodservice Disposables LLCLZA2024-05-14
00847212008468Elara BrandsElara Foodservice Disposables LLCLZC2024-05-14
00847212008475Elara BrandsElara Foodservice Disposables LLCLZA2024-05-14
00847212008475Elara BrandsElara Foodservice Disposables LLCLZC2024-05-14