CALICO NG002S

GUDID 10850044458063

NITRILE EXAM GLOVE S

Calico Medical Group LLC

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: 10850044458063
• NIH Device Record Key: ec17e86c-a9ea-4d34-aa66-dd8460c305a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CALICO
• Version Model Number: NG002S
• Catalog Number: NG002S
• Company DUNS: 118744421
• Company Name: Calico Medical Group LLC
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 619-454-1048
• Email: msmith@calicomed.com
• Phone: 619-454-1048
• Email: msmith@calicomed.com
• Phone: 619-454-1048
• Email: msmith@calicomed.com
• Phone: 619-454-1048
• Email: msmith@calicomed.com
• Phone: 619-454-1048
• Email: msmith@calicomed.com
• Phone: 619-454-1048
• Email: msmith@calicomed.com
• Phone: 619-454-1048
• Email: msmith@calicomed.com
• Phone: 619-454-1048
• Email: msmith@calicomed.com
• Phone: 619-454-1048
• Email: msmith@calicomed.com
• Phone: 619-454-1048
• Email: msmith@calicomed.com
• Phone: 619-454-1048
• Email: msmith@calicomed.com
• Phone: 619-454-1048
• Email: msmith@calicomed.com
• Phone: 619-454-1048
• Email: msmith@calicomed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850044458066 [Primary]
GS1	10850044458063 [Unit of Use]
GS1	20850044458060 [Package]; Contains: 00850044458066; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200539

FDA Product Code

• LZA: Polymer Patient Examination Glove

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-25
• Device Publish Date: 2022-08-17

On-Brand Devices [CALICO]

• 00850044458035: ITNG001M
• 00850044458011: Product: Glove Type: Exam Material: Nitrile Size: Medium Fingertip Thickness: 3.5g Standard Cuff
• 00850044458004: Product: Glove Type: Exam Material: Nitrile Size: Medium Fingertip Thickness: 3.5g Chemo Tested:
• 20850044458336: LATEX EXAM GLOVE XL
• 10850044458322: LATEX EXAM GLOVE L
• 20850044458312: LATEX EXAM GLOVE M
• 20850044458305: LATEX EXAM GLOVE S
• 20850044458299: LATEX EXAM GLOVE XS
• 20850044458213: NITRILE EXAM GLOVE XL
• 10850044458209: NITRILE EXAM GLOVE L
• 10850044458193: NITRILE EXAM GLOVE M
• 10850044458186: NITRILE EXAM GLOVE S
• 20850044458176: NITRILE EXAM GLOVE XS
• 10850044458131: NITRILE EXAM GLOVE XL
• 10850044458124: NITRILE EXAM GLOVE L
• 10850044458117: NITRILE EXAM GLOVE M
• 10850044458100: NITRILE EXAM GLOVE S
• 10850044458094: NITRILE EXAM GLOVE XS
• 10850044458087: NITRILE EXAM GLOVE XL
• 10850044458070: NITRILE EXAM GLOVE L
• 10850044458063: NITRILE EXAM GLOVE S
• 10850044458056: Nitrile Exam Glove XS
• 20850044458541: AG Silver Silicone Foam Dressing, Bordered, 6" x 6"
• 20850044458534: AG Silver Silicone Foam Dressing, Bordered, 4" x 4"
• 20850044458527: AG Silver Silicone Foam Dressing, Bordered, 2" x 2"
• 20850044458688: Antimicrobial Gauze
• 10850044458674: Antimicrobial Super Sponge 4.5X4.1 Yards-6P,EO
• 20850044458664: Super Absorbent Dressing, Carbon Silicone, 4X4
• 20850044458657: Super Absorbent Dressing, Silicone, Non Border, 4X4
• 20850044458640: Super Absorbent Dressing 4X4
• 20850044458633: Silicone Foam Dressing, Non Bordered, 6" x 6"
• 20850044458626: Silicone Foam Dressing, Non Bordered, 4" x 4"
• 10850044458612: Silicone Foam Dressing, Non Bordered, 2" x 2"
• 20850044458602: Foam Dressing, PU Waterproof w/ Border 6" x 6"
• 20850044458596: Foam Dressing, PU Waterproof w/ Border 4" x 4"
• 20850044458589: Foam Dressing, PU Waterproof w/ Border 2" x 2"
• 20850044458572: Non Adhesive Foam Dressing, PU Waterproof 6" x 6"
• 20850044458565: Non Adhesive Foam Dressing, PU Waterproof 4" x 4"
• 20850044458558: Non Adhesive Foam Dressing, PU Waterproof 2" x 2"
• 20850044458466: Silver Calcium Alginate Dressing 6" x 6"
• 20850044458459: Silver Calcium Alginate Dressing 4" x 4"
• 20850044458442: Silver Calcium Alginate Dressing 2" x 2"
• 20850044458435: Silicone Bordered Foam Dressing Heel 5.3" x 6"
• 20850044458411: Silicone Bordered Foam Dressing Sacral Large
• 20850044458404: Silicone Bordered Foam Dressing Sacral Small
• 20850044458398: Silicone Bordered Foam Dressing 6" x 6"
• 20850044458381: Silicone Bordered Foam Dressing 4" x 4"
• 20850044458374: Silicone Bordered Foam Dressing 2" x 2"
• 20850044458367: Calcium Alginate Dressing 6" x 6"
• 20850044458350: Calcium Alginate Dressing 4" x 4"