Protect U Guard Nitro-Lion LD Nitrile Patient Exam P10124

GUDID B086201242

Protect U Guard Nitro-Lion LD Nitrile Patient Examination Glove , Single Use, Non-Sterile, Powder Free, Low Dermatitis Potential Box of 250 Gloves

PROTECT U GUARD, LLC

Nitrile examination/treatment glove, non-powdered, non-sterile
Primary Device IDB086201242
NIH Device Record Key9aef069b-3bb8-4b58-918b-0d36559903d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameProtect U Guard Nitro-Lion LD Nitrile Patient Exam
Version Model NumberP10124
Catalog NumberP10124
Company DUNS080070945
Company NamePROTECT U GUARD, LLC
Device Count250
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB086101240 [Unit of Use]
HIBCCB086101241 [Primary]
HIBCCB086201242 [Package]
Contains: B086101241
Package: Carton [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZCPatient Examination Glove, Specialty

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-27
Device Publish Date2018-08-27

On-Brand Devices [Protect U Guard Nitro-Lion LD Nitrile Patient Exam]

B086201242Protect U Guard Nitro-Lion LD Nitrile Patient Examination Glove , Single Use, Non-Sterile, Powde
B086201232Protect U Guard Nitro-Lion LD Nitrile Patient Examination Glove , Single Use, Non-Sterile, Powde
B086201222Protect U Guard Nitro-Lion LD Nitrile Patient Examination Glove , Single Use, Non-Sterile, Powde
B086201212Protect U Guard Nitro-Lion LD Nitrile Patient Examination Glove , Single Use, Non-Sterile, Powde

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