FDA.reportPublic FDA data

Ocean Pacific NeoNatural

Primary DI
10686864056086
Brand
Ocean Pacific NeoNatural
Company
AMD Medicom Inc
Model
1228-E
Catalog number
1228-E
Device description
Ocean Pacific NeoNatural - Polychloroprene Medical Examination Gloves - Chemotherapy Tested - Textured Fingertips - Powder Free - Non-Sterile - Chemical Resistant Emerald - X-Large
Published
2022-06-28
Public version status
Update
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040607000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040607000MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVESPt. Medisafe Technologies2004-04-22LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20686864056083PackageGS110In Commercial Distribution
10686864056086PrimaryGS10
00686864056089Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2068686405608320686864056083
1068686405608610686864056086
00686864056089006868640560896868640560890686864056089

GMDN Terms#

Term, Definition table
TermDefinition
Polychloroprene examination/treatment glove, non-powderedA device made of polychloroprene (neoprene) 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/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. 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, Specify00Cool dry place - Avoid excessive heat (40°C/104°F)

Contacts#

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

Regulatory Flags#

DUNS number
256880576
Device count
100
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10686864061905MEDICOM SAFESEAL76024760242026-06-25
10686864061912MEDICOM SAFESEAL76030760302026-06-25
10686864061929MEDICOM SAFESEAL76036760362026-06-25
10686864061936MEDICOM ASSUREMASK VALIANT205915-B205915-B2026-03-17
10686864061943MEDICOM ASSUREMASK VALIANT205915-C205915-C2026-03-17
20686864061933MEDICOM ASSUREMASK VALIANT205915-B205915-B2026-03-17
20686864061940MEDICOM ASSUREMASK VALIANT205915-C205915-C2026-03-17
10686864060946MEDICOM DENTICARE 10067100672026-02-25
10686864060953MEDICOM DENTICARE 10068100682026-02-25
20686864060943MEDICOM DENTICARE 10067100672026-02-25
20686864060950MEDICOM DENTICARE 10068100682026-02-25
D8304405061PROFESSIONAL'S CHOICE4405064405062026-02-10
D8305514331MEDICOM5514335514332026-02-10
D8304405062PROFESSIONAL'S CHOICE4405064405062026-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850005229803NeulynxMedgluv Inc.LZA2026-07-17
00850005229810NeulynxMedgluv Inc.LZA2026-07-17
00850005229827NeulynxMedgluv Inc.LZA2026-07-17
00850005229834NeulynxMedgluv Inc.LZA2026-07-17
00850005229841NeulynxMedgluv Inc.LZA2026-07-17
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZA2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZA2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZA2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZA2026-07-14
10686864061950Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061967Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061974Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
00196633795618Kirkland SignatureCostco Wholesale CorporationLZA2026-07-10
10697383979435GloveworksAMMEX CORPORATIONLZA2026-07-10
20697383979432GloveworksAMMEX CORPORATIONLZA2026-07-10
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810145952115NeuleafMedgluv Inc.LZA2026-06-30
00810145952122NeuleafMedgluv Inc.LZA2026-06-30
00810145952139NeuleafMedgluv Inc.LZA2026-06-30
00810145952146NeuleafMedgluv Inc.LZA2026-06-30
00810145952108NeuleafMedgluv Inc.LZA2026-06-29
00850005229568NeuflexMedgluv Inc.LZA2026-06-29
00850005229575NeuflexMedgluv Inc.LZA2026-06-29
00850005229582NeuflexMedgluv Inc.LZA2026-06-29
00850005229599NeuflexMedgluv Inc.LZA2026-06-29
00850005229605NeuflexMedgluv Inc.LZA2026-06-29