FDA.reportPublic FDA data

microdot®

Primary DI
00847713000411
Brand
microdot®
Company
Cambridge Sensors USA LLC
Model
1202-10
Device description
Nitrile Powder Free Examination Gloves (Medium)
Published
2022-11-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FMCPatient Examination Glove
LZAPolymer Patient Examination Glove
LZCPatient Examination 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
FMCPatient Examination GloveGeneral Hospital1
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
K182554000
K222815000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182554000Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy DrugsHe Chuang Plastic & Rubber Co., Ltd.2019-03-22LZA
K222815000Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and FentanylZibo Lanhua Medical Packaging Material Co., Ltd.2022-12-04LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847713000428PackageGS110In Commercial Distribution
00847713000411PrimaryGS10
00847713000534Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847713000428008477130004288477130004280847713000428
00847713000411008477130004118477130004110847713000411
00847713000534008477130005348477130005340847713000534

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
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
00847713000930microdot® Pro Gloves1401-102025-02-18
00847713000947microdot® Pro Gloves1402-102025-02-18
00847713000954microdot® Pro Gloves1403-102025-02-18
00847713000961microdot® Pro Gloves1404-102025-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850084857331MedClickMedClick LLCLZA2026-07-22
00850084857348MedClickMedClick LLCLZA2026-07-22
00850084857355MedClickMedClick LLCLZA2026-07-22
00850084857362MedClickMedClick LLCLZA2026-07-22
00850084857379MedClickMedClick LLCLZA2026-07-22
00850084857386MedClickMedClick LLCLZA2026-07-22
00850084857393MedClickMedClick LLCLZA2026-07-22
00850084857409MedClickMedClick LLCLZA2026-07-22
05060264110056Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110063Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110070Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110087Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
05060264110094Violet Pearl NitrileUg Healthcare (usa), Inc.LZA2026-07-20
00850005229803NeulynxMedgluv Inc.OPJ2026-07-17
00850005229803NeulynxMedgluv Inc.LZA2026-07-17
00850005229803NeulynxMedgluv Inc.QDO2026-07-17
00850005229810NeulynxMedgluv Inc.LZA2026-07-17
00850005229810NeulynxMedgluv Inc.QDO2026-07-17
00850005229810NeulynxMedgluv Inc.OPJ2026-07-17
00850005229827NeulynxMedgluv Inc.LZA2026-07-17
00850005229827NeulynxMedgluv Inc.QDO2026-07-17
00850005229827NeulynxMedgluv Inc.OPJ2026-07-17
00850005229834NeulynxMedgluv Inc.LZA2026-07-17
00850005229834NeulynxMedgluv Inc.OPJ2026-07-17
00850005229834NeulynxMedgluv Inc.QDO2026-07-17
00850005229841NeulynxMedgluv Inc.LZA2026-07-17
00850005229841NeulynxMedgluv Inc.QDO2026-07-17
00850005229841NeulynxMedgluv Inc.OPJ2026-07-17
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.QDO2026-07-14
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZC2026-07-14