FDA.reportPublic FDA data

CALICO

Primary DI
00850044458097
Brand
CALICO
Company
Calico Medical Group LLC
Model
NG006XS
Catalog number
NG006XS
Device description
NITRILE EXAM GLOVE XS
Published
2022-08-17
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
LZCPatient Examination Glove, Specialty
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183287000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183287000Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl CitrateKossan International Sdn Bhd2019-04-05LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850044458091PackageGS110In Commercial Distribution
00850044458097PrimaryGS10
10850044458094Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085004445809120850044458091
00850044458097008500444580978500444580970850044458097
1085004445809410850044458094

Contacts#

Phone, Email table
PhoneEmail
619-454-1048msmith@calicomed.com

Regulatory Flags#

DUNS number
118744421
Device count
100
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850044458684CALICOGZ001GZ0012022-08-22
00810120640006CALICOLG009LG0092022-09-09
00810120640013CALICOLG010LG0102022-09-09
00810120640020CALICONG021NG0212022-09-09
00810120640037CALICONG022NG0222022-09-09
00810120640044CALICONG023NG0232022-09-09
00810120640051CALICONG024NG0242022-09-09
00810120640068CALICONG025NG0252022-09-09
00850044458981CALICOLG007LG0072022-09-09
00850044458998CALICOLG008LG0082022-09-09
20810120640000CALICOLG009LG0092022-09-09
10810120640010CALICOLG010LG0102022-09-09
20810120640024CALICONG021NG0212022-09-09
20810120640031CALICONG022NG0222022-09-09
20810120640048CALICONG023NG0232022-09-09
20810120640055CALICONG024NG0242022-09-09
20810120640062CALICONG025NG0252022-09-09
10850044458988CALICOLG007LG0072022-09-09
10850044458995CALICOLG008LG0082022-09-09
00850044458929CALICONG016NG0162022-09-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00366975073358BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
00366975073365BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
00366975073372BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
00366975073389BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
10850061371246American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371246American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371246American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371260American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371260American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371260American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371284American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371284American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371284American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371291American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371291American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371291American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371307American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371307American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371307American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371314American Health and SafetyLabsource, Inc.QDO2026-11-02
10850061371314American Health and SafetyLabsource, Inc.LZC2026-11-02
10850061371314American Health and SafetyLabsource, Inc.LZA2026-11-02
05060655503450Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
05060655503467Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
05060655503474Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
05060655503481Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
05060655504006Unigloves Biotouch BlackUg Healthcare (usa), Inc.LZA2026-11-01
10809160542118HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-28
10809160541722HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26