FDA.reportPublic FDA data

Medicom AssureTouch

Primary DI
10686864061370
Brand
Medicom AssureTouch
Company
AMD Medicom Inc
Model
9940-A
Catalog number
9940-A
Device description
Medicom AssureTouch Ultra - Nitrile Medical Examination Gloves - Textured Fingertips - Powder Free - Non-Sterile - Violet Blue - Extra-Small
Published
2025-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
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
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
K221165000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221165000Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and FentanylSri Trang Gloves (Thailand) Public Company Limited2022-11-20LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20686864061377PackageGS110In Commercial Distribution
10686864061370PrimaryGS10
00686864061373Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2068686406137720686864061377
1068686406137010686864061370
00686864061373006868640613736868640613730686864061373

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry place. Avoid excessive heat (30°C, 86°F).

Contacts#

Phone, Email table
PhoneEmail
+1(514)636-6262mdasilva@medicom.ca

Regulatory Flags#

DUNS number
256880576
Device count
200
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10686864044434AMD-RITMED85992C85992C2019-01-15
10686864044441AMD-RITMED85993C85993C2019-01-15
10686864044458AMD-RITMED85994C85994C2019-01-15
10686864044465AMD-RITMED85995C85995C2019-01-15
10686864044472AMD-RITMED85996C85996C2019-01-15
10686864044489AMD-RITMED85997C85997C2019-01-15
10686864044496AMD-RITMED85998C85998C2019-01-15
20686864043205AMD-RITMED55992C55992C2019-01-15
20686864043212AMD-RITMED55993C55993C2019-01-15
20686864043229AMD-RITMED55994C55994C2019-01-15
20686864043236AMD-RITMED55995C55995C2019-01-15
20686864043243AMD-RITMED55996C55996C2019-01-15
20686864043250AMD-RITMED55997C55997C2019-01-15
20686864043267AMD-RITMED55998C55998C2019-01-15
10686864061950Ocean Pacific NeoNatural1228B-SP101228B-SP102026-07-13
10686864061967Ocean Pacific NeoNatural1228C-SP101228C-SP102026-07-13
10686864061974Ocean Pacific NeoNatural1228D-SP101228D-SP102026-07-13
10686864061868MEDICOM SAFESEAL76112761122026-06-25
10686864061875MEDICOM SAFESEAL76115761152026-06-25
10686864061899MEDICOM SAFESEAL76020760202026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199972000641CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000641CuraplexBOUND TREE MEDICAL, LLCQDO2026-10-15
00199972000641CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000672CuraplexBOUND TREE MEDICAL, LLCQDO2026-10-15
00199972000672CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000672CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000702CuraplexBOUND TREE MEDICAL, LLCQDO2026-10-15
00199972000702CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000702CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000733CuraplexBOUND TREE MEDICAL, LLCQDO2026-10-15
00199972000733CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000733CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000764CuraplexBOUND TREE MEDICAL, LLCQDO2026-10-15
00199972000764CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000764CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00850069531010Elevate BluMaxter Healthcare IncorporatedQDO2026-10-15
00850069531010Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531010Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531010Elevate BluMaxter Healthcare IncorporatedOPJ2026-10-15
00850069531027Elevate BluMaxter Healthcare IncorporatedQDO2026-10-15
00850069531027Elevate BluMaxter Healthcare IncorporatedOPJ2026-10-15
00850069531027Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531027Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531034Elevate BluMaxter Healthcare IncorporatedQDO2026-10-15
00850069531034Elevate BluMaxter Healthcare IncorporatedOPJ2026-10-15
00850069531034Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531034Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531041Elevate BluMaxter Healthcare IncorporatedQDO2026-10-15
00850069531041Elevate BluMaxter Healthcare IncorporatedOPJ2026-10-15
00850069531041Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15