FDA.reportPublic FDA data

CALICO

Primary DI
10850044458131
Brand
CALICO
Company
Calico Medical Group LLC
Model
NG010XL
Catalog number
NG010XL
Device description
NITRILE EXAM GLOVE XL
Published
2022-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
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
20850044458138PackageGS110In Commercial Distribution
00850044458134PrimaryGS10
10850044458131Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085004445813820850044458138
00850044458134008500444581348500444581340850044458134
1085004445813110850044458131

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
118744421
Device count
100
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00366975073341BENCO DENTALBENCO DENTAL SUPPLY CO.LZA2026-11-04
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.LZA2026-11-02
10850061371260American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371284American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371291American Health and SafetyLabsource, Inc.LZA2026-11-02
10850061371307American Health and SafetyLabsource, Inc.LZA2026-11-02
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
00724312268568VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992639VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992646VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
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00755676002581mvetADI MedicalLZA2026-10-23
00755676002611mvetADI MedicalLZA2026-10-23
00755676002765mvetADI MedicalLZA2026-10-23
00755676002796mvetADI MedicalLZA2026-10-23
00755676002826mvetADI MedicalLZA2026-10-23
00755676002857mvetADI MedicalLZA2026-10-23
00755676002994mvetADI MedicalLZA2026-10-23