HANDCOVERS

GUDID 00850051992171

4 Mil Powder-Free Black Nitrile Gloves, Size Small

Balco Industries Inc.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID00850051992171
NIH Device Record Keya1f33de5-1d72-49fb-ab62-1b276ba805b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameHANDCOVERS
Version Model NumberBKN4001
Company DUNS055891774
Company NameBalco Industries Inc.
Device Count100
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850051992164 [Primary]
GS100850051992171 [Package]
Contains: 00850051992164
Package: [10 Units]
In Commercial Distribution
GS130850051992165 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZAPolymer Patient Examination Glove

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-10
Device Publish Date2023-07-01

On-Brand Devices [HANDCOVERS]

008500519921576 Mil Powder-Free Black Nitrile Gloves, Size XL
008500519921336 Mil Powder-Free Black Nitrile Gloves, Size Large
008500519921196 Mil Powder-Free Black Nitrile Gloves, Size Medium
008500519920966 Mil Powder-Free Black Nitrile Gloves, Size Small
008500519920724 Mil Powder-Free Blue Nitrile Gloves, Size XL
008500519920584 Mil Powder-Free Blue Nitrile Gloves, Size Large
008500519920344 Mil Powder-Free Blue Nitrile Gloves, Size Medium
008500519920104 Mil Powder-Free Blue Nitrile Gloves, Size Small
008500519922324 Mil Powder-Free Black Nitrile Gloves, Size XL
008500519922184 Mil Powder-Free Black Nitrile Gloves, Size Large
008500519921954 Mil Powder-Free Black Nitrile Gloves, Size Medium
008500519921714 Mil Powder-Free Black Nitrile Gloves, Size Small
008500519922564 Mil Powder-Free Rose Nitrile Gloves, Size Small
008500519923174 Mil Powder-Free Rose Nitrile Gloves, Size Xlarge
008500519922944 Mil Powder-Free Rose Nitrile Gloves, Size Large
008500519922704 Mil Powder-Free Rose Nitrile Gloves, Size Medium

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