FDA.reportPublic FDA data

Protect U Guard Nitro-Lion LD Nitrile Patient Exam

Primary DI
B086201242
Brand
Protect U Guard Nitro-Lion LD Nitrile Patient Exam
Company
PROTECT U GUARD, LLC
Model
P10124
Catalog number
P10124
Device description
Protect U Guard Nitro-Lion LD Nitrile Patient Examination Glove , Single Use, Non-Sterile, Powder Free, Low Dermatitis Potential Box of 250 Gloves
Published
2018-08-27
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

Product Codes#

Code, Name table
CodeName
LZCPatient Examination Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151824000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151824000Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy DrugsKossan International Sdn Bhd2016-08-02LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B086201242PackageHIBCC10In Commercial Distribution
B086101241PrimaryHIBCC0
B086101240Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-sterileA non-sterile 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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080070945
Device count
250
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
true
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
B086191501Protect U Guard U-Shaped IV Transparent DressingP191502020-08-21
B086191511Protect U Guard Transparent Sterile DressingP191512020-08-21
B086191541Protect U Guard Transparent Sterile Dressing PU InciseP191542020-08-21
B086202012Protect U Guard Bouffant Cap BlueP202012017-02-24
B086202022Protect U Guard Bouffant Cap YellowP202022017-02-24
B086203012Protect U Guard Doctor Cap BlueP203012017-02-24
B086191311Protect U Guard Silicone Foam Sterile DressingP191312020-08-21
B086191321Protect U Guard Silicone Foam Sterile DressingP191322020-08-21
B086105051Protect U Guard CPE Isolation GownP105052021-02-02
B086205052Protect U Guard CPE Isolation GownP105052021-02-02
B086191001Protect U Guard Hydrocolloid Sterile DressingP191002020-08-21
B086191011Protect U Guard Hydrocolloid Sterile DressingP191012020-08-21
B086191021Protect U Guard Hydrocolloid Sterile DressingP191022020-08-21
B086191031Protect U Guard Hydrocolloid Sterile DressingP191032020-08-21
B086191041Protect U Guard Hydrocolloid With Foam Backing Sterile DressingP191042020-08-21
B086191101Protect U Guard Alginate Sterile DressingP191102020-08-21
B086191111Protect U Guard Alginate Sterile DressingP191112020-08-21
B086191121Protect U Guard Alginate Sterile DressingP191122020-08-21
B086191231Protect U Guard Non-Woven DressingP191232020-08-21
B086191241Protect U Guard Non-Woven DressingP291242020-08-21

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