FDA.reportPublic FDA data

Ocean Pacific NeoNatural

Primary DI
20686864056045
Brand
Ocean Pacific NeoNatural
Company
AMD Medicom Inc
Model
1228-A
Catalog number
1228-A
Device description
Ocean Pacific NeoNatural - Polychloroprene Medical Examination Gloves - Chemotherapy Tested - Textured Fingertips - Powder Free - Non-Sterile - Chemical Resistant Emerald - X-Small
Published
2022-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
K981064000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040607000MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVESPt. Medisafe Technologies2004-04-22LZA
K981064000POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVESP.T. Irama Dinamika Latex1998-11-05LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20686864056045PackageGS110In Commercial Distribution
10686864056048PrimaryGS10
00686864056041Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2068686405604520686864056045
1068686405604810686864056048
00686864056041006868640560416868640560410686864056041

GMDN Terms#

Term, Definition table
TermDefinition
Polychloroprene examination/treatment glove, non-powderedA non-sterile 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 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/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)

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
256880576
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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

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Primary DI, Brand, Company table
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