Darby Dental Supply, LLC 5255410

GUDID 20889813060098

GLOVE NITR PRO HANDSON BLK S

DARBY DENTAL SUPPLY, LLC

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

• Primary Device ID: 20889813060098
• NIH Device Record Key: 4fb30539-e969-4ed0-8103-42410f58be61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Darby Dental Supply, LLC
• Version Model Number: 5255410
• Catalog Number: 5255410
• Company DUNS: 825137818
• Company Name: DARBY DENTAL SUPPLY, LLC
• Device Count: 300
• DM Exempt: true
• 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: true
• Expiration Date: false
• 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: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889813060094 [Primary]
GS1	10889813060091 [Unit of Use]
GS1	20889813060098 [Package]; Contains: 00889813060094; Package: case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001619

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: 2023-07-24
• Device Publish Date: 2023-07-14

On-Brand Devices [Darby Dental Supply, LLC]

• D82795320301: Cone Molded Earloop Face Mask
• D82795187361: MASK FORM FIT CONE PINK SMALL
• D82795187351: MASK FORM FIT CONE BLUE REGULAR
• D82795187221: MASK CONE MOLDED SMALL PINK
• D82795186891: MASK CONE MOLDED STANDARD BLUE
• D82795151031: MASK SURGICAL TIE-ON BLUE
• D82795004250: ALGINATE DUSTLESS FAST SET 22LB
• D82795004200: ALGINATE DUSTLESS REGULAR SET 22LB
• D82795004150: ALGINATE DUSTLESS REGULAR SET 1LB
• D82795004100: ALGINATE DUSTLESS FAST SET 1LB
• D82794306620: Temporary Filling Material Syringe 5g
• D82794306600: Temporary Filling Material 18g Jar
• 00366467000015: HEDSTROM FILE W/STOP 21MM #15 DARBY
• 40889813000678: STERILIZATION POUCH 3.5 X 9
• 10889813017958: 5% Clear Sodium Fluoride Varnish Melon 500ct
• 10889813017941: 5% Clear Sodium Fluoride Varnish Melon 50ct
• 10889813017927: 5% Clear Sodium Fluoride Varnish Mint 500ct
• 10889813017910: 5% Clear Sodium Fluoride Varnish Mint 50ct
• 10889813017897: 5% SODIUM FL VARNISH CARAMEL DARBY
• 10889813017880: 5% SODIUM FL VARNISH CARAMEL DARBY
• 10889813017866: 5% SODIUM FL CLR VARNISH BGUM DARBY
• 10889813017859: 5% SODIUM FL CLR VARNISH BGM DARBY
• 10889813013899: MIRROR SIMPLE STEM PLANE #5 DARBY
• 10889813004125: CARBIDE BUR FG 7803 DARBY
• 10889813003234: SUTURE SILK 3/8 NC-2 3/0 18" DARBY
• 10889813002695: Pit & Fissure Sealant
• 10889813002466: Polysiloxane Bite Super Fast Set Wintermint 50ml CART
• 10889813002107: PVS Impression Material Regular Set Light Body Raspberry 50ML
• 10889813001933: PVS Impression Material Fast Set Light Body Wintermint 50ml
• 10889813001926: PVS Impression Material Regular Set Light Body Wintermint 50ml
• 10889813001919: PVS Impression Material Fast Set Heavy Body Unflav 50ml
• 10889813001902: PVS Impression Material Fast Set Monophase Body Unflav 50ml
• 10889813001896: PVS Impression Material Fast Set Medium Body Unflav 50ml
• 10889813001889: PVS Impression Material Fast Set Light Body Unflavored 50ml
• 10889813001773: Cone Molded Earloop Face Mask
• 10889813001766: MASK FORM FIT CONE PINK SMALL
• 10889813001759: MASK FORM FIT CONE BLUE REGULAR
• 10889813001742: MASK CONE MOLDED SMALL PINK
• 10889813001735: MASK CONE MOLDED STANDARD BLUE
• 10889813001728: MASK SURGICAL TIE-ON BLUE
• 10889813001698: Alginate Substitute Fast Set 50ml CART
• 10889813001681: Alginate Substitute Regular Set 50ml CART
• 20889813001428: SLEEVE T-STYLE HANDLE
• 20889813001411: CHAIR SLEEVE HALF 27.5 x 24
• 20889813001404: CHAIR SLEEVE FULL 29" X 80"
• 20889813001398: X-Ray Sleeves 15x26
• 20889813001381: TRAY SLEEVES 10.5" X 14"
• 20889813001374: TRAY SLEEVES 11.5" X 16"
• 20889813001367: Low-speed handpiece sleeves 1.5 x 8
• 20889813001350: Syringe Sleeves A/W Clear