FDA.reportPublic FDA data

Wave Blue Nitrile Examination Gloves Powder Free

Primary DI
00843812168496
Brand
Wave Blue Nitrile Examination Gloves Powder Free
Company
C&A Marketing, Inc.
Model
Small
Catalog number
WVEBNGS
Device description
Non-powdered patient examination gloves
Published
2023-02-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K202384000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202384000Palm Care Blue Nitrile Examination Gloves Powder FreeHi-Care Thai Gloves Co. , Ltd.2020-12-02LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10843812168493PackageGS11000In Commercial Distribution
00843812168496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084381216849310843812168493
00843812168496008438121684968438121684960843812168496

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from direct sunlight, moisture, ozone and X-rays. Store in a cool, dry place. Improper storage may reduce shelf life.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-848-244-2343casales@caglobal.com

Regulatory Flags#

DUNS number
134723316
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843812168434Wave Blue Nitrile Examination Gloves Powder FreeLargeWVEBNGL2023-02-22
00843812168458Wave Blue Nitrile Examination Gloves Powder FreeX LargeWVEBNGXL2023-02-22
00843812168502Wave Blue Nitrile Examination Gloves Powder FreeMediumWVEBNGM2023-02-22
00843812172783Truvitals Upper Arm Blood Pressure Monitor (BPA200)GEBPA2002023-01-10
00843812173254Truvitals Upper Arm Blood Pressure Monitor (BPA400)GEBPA4002023-01-10
00843812173278Truvitals Wrist Blood Pressure Monitor (BPW100)GEBPW1002023-01-10
00843812175180Truvitals Smart Upper Arm Blood Pressure Monitor with Bluetooth (BPA600)GEBPA6002023-01-10
00843812175197Truvitals Smart Wrist Blood Pressure Monitor with Bluetooth (BPW500)GEBPW5002023-01-10

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