FDA.reportPublic FDA data

microdot® Flex

Primary DI
00847713001371
Brand
microdot® Flex
Company
Cambridge Sensors USA LLC
Model
1504-10
Device description
microdot® Flex Nitrile X-Large Gloves
Published
2025-12-12
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
K222298000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222298000Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric AcidOnetexx Sdn Bhd2022-10-18LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847713001371PackageGS110In Commercial Distribution
00847713001326PrimaryGS10
00847713001272Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847713001371008477130013718477130013710847713001371
00847713001326008477130013268477130013260847713001326
00847713001272008477130012728477130012720847713001272

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
962314360
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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
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
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
00847713000978microdot® Pro Gloves1405-102025-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194346693122EquateWAL-MART STORES, INC.LZA2026-06-02
00194346693139EquateWAL-MART STORES, INC.LZA2026-06-02
00768627017282Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017299Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017305Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017312Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
10840330702208ProCureTwin Med, LLCLZA2026-06-01
10840330702215ProCureTwin Med, LLCLZA2026-06-01
10840330702222ProCureTwin Med, LLCLZA2026-06-01
10840330702239ProCureTwin Med, LLCLZA2026-06-01
10840330702246ProCureTwin Med, LLCLZA2026-06-01
10840330706756ProCureTwin Med, LLCLZA2026-06-01
10840330706763ProCureTwin Med, LLCLZA2026-06-01
10840330706770ProCureTwin Med, LLCLZA2026-06-01
10840330706787ProCureTwin Med, LLCLZA2026-06-01
10840330706794ProCureTwin Med, LLCLZA2026-06-01
10860015093728MaadhoMaadho Distributors Inc.LZA2026-06-01
10860015093735MaadhoMaadho Distributors Inc.LZA2026-06-01
10860015093742MaadhoMaadho Distributors Inc.LZA2026-06-01
10860015093759MaadhoMaadho Distributors Inc.LZA2026-06-01
10840330702000ProCureTwin Med, LLCLZA2026-05-29
10840330702024ProCureTwin Med, LLCLZA2026-05-29
10840330702048ProCureTwin Med, LLCLZA2026-05-29
10840330702062ProCureTwin Med, LLCLZA2026-05-29
10840330702086ProCureTwin Med, LLCLZA2026-05-29
10840330702109ProCureTwin Med, LLCLZA2026-05-29
10840330702123ProCureTwin Med, LLCLZA2026-05-29
10840330702147ProCureTwin Med, LLCLZA2026-05-29
10840330702161ProCureTwin Med, LLCLZA2026-05-29
10840330702185ProCureTwin Med, LLCLZA2026-05-29