Shield Gloves

GUDID 00850046161858

Black Nitrile Glove, Exam Grade, Powder Free, Finger Textured, Medium, Inner Pack

B D G Wrap-Tite, Inc.

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

• Primary Device ID: 00850046161858
• NIH Device Record Key: 6efe83ac-0210-42fe-b96a-d8bd4af5172a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shield Gloves
• Version Model Number: GLNMPFB6-M
• Company DUNS: 076901110
• Company Name: B D G Wrap-Tite, Inc.
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850046161858 [Unit of Use]
GS1	00850046161865 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133307

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: 2022-12-14
• Device Publish Date: 2022-12-06

On-Brand Devices [Shield Gloves]

• 00850046161704: Blue Nitrile Glove, Exam Grade, Powder Free, Finger Textured, Small, Inner Pack
• 00850046161674: Blue Nitrile Glove, Exam Grade, Powder Free, Finger Textured, Medium, Inner Pack
• 00850046161643: Blue Nitrile Glove, Exam Grade, Powder Free, Finger Textured, Large, Inner Pack
• 00850046161605: Blue Nitrile Glove, Exam Grade, Powder Free, Finger Textured, Extra Large, Inner Pack
• 00850046161124: Latex Gloves, Exam Grade, Powder Free, Finger Textured, Extra Large, Inner Pack
• 00850046161063: Latex Gloves, Exam Grade, Powder Free, Finger Textured, Natural Color, Medium, Inner Pack
• 00850046161094: Latex Gloves, Exam Grade, Powder Free, Finger Textured, Large, Inner Pack
• 00850046161018: Latex Gloves, Exam Grade, Powder Free, Finger Textured, Small, Inner Pack
• 00850046161520: Black Nitrile Glove, Exam Grade, Powder Free, Finger Textured, 2XL, Inner Pack
• 00850046161490: Black Nitrile Glove, Exam Grade, Powder Free, Finger Textured, Extra Large, Inner Pack
• 00850046161469: Black Nitrile Glove, Exam Grade, Powder Free, Finger Textured, Large, Inner Pack
• 00850046161438: Black Nitrile Glove, Exam Grade, Powder Free, Finger Textured, Medium, Inner Pack
• 00850046161407: Black Nitrile Glove, Exam Grade, Powder Free, Finger Textured, Small, Inner Pack
• 00850046161827: Clear Vinyl Gloves, Exam Grade, Powder Free, Smooth Finish, Extra Large, Inner Pack
• 00850046161797: Clear Vinyl Gloves, Exam Grade, Powder Free, Smooth Finish, Large, Inner Pack
• 00850046161766: Clear Vinyl Gloves, Exam Grade, Powder Free, Smooth Finish, Medium, Inner Pack
• 00850046161735: Clear Vinyl Gloves, Exam Grade, Powder Free, Smooth Finish, Small, Inner Pack
• 00850046161223: Black Nitrile Glove, Exam Grade, Powder Free, Fully Textured, Small, Inner Pack
• 00850046161193: Black Nitrile Glove, Exam Grade, Powder Free, Fully Textured, Medium, Inner Pack
• 00850046161377: Orange Nitrile Glove, Exam Grade, Powder Free, Fully Textured, 2XL, Inner Pack
• 00850046161346: Orange Nitrile Glove, Exam Grade, Powder Free, Fully Textured, Extra Large, Inner Pack
• 00850046161315: Orange Nitrile Glove, Exam Grade, Powder Free, Fully Textured, Large, Inner Pack
• 00850046161285: Orange Nitrile Glove, Exam Grade, Powder Free, Fully Textured, Medium, Inner Pack
• 00850046161254: Orange Nitrile Glove, Exam Grade, Powder Free, Fully Textured, Small, Inner Pack
• 00850046161162: Black Nitrile Glove, Exam Grade, Powder Free, Fully Textured, Large, Inner Pack
• 00850046161131: Black Nitrile Glove, Exam Grade, Powder Free, Fully Textured, Extra Large, Inner Pack
• 00850046161032: Black Nitrile Glove, Exam Grade, Powder Free, Fully Textured, 2XL, Inner Pack
• 00850046161940: Black Nitrile Glove, Exam Grade, Powder Free, Finger Textured, 2XL, Inner Pack
• 00850046161919: Black Nitrile Glove, Exam Grade, Powder Free, Finger Textured, XL, Inner Pack
• 00850046161889: Black Nitrile Glove, Exam Grade, Powder Free, Finger Textured, Large, Inner Pack
• 00850046161858: Black Nitrile Glove, Exam Grade, Powder Free, Finger Textured, Medium, Inner Pack
• 00850048574120: Latex Gloves, Exam Grade, Powder Free, Finger Textured, Extra Small, Inner Pack
• 00850046161575: Blue Nitrile Glove, Exam Grade, Powder Free, Finger Textured, 2XL, Inner Pack
• 00850048574632: Nitrile Gloves, Exam Grade, Powder Free, Orange, Full Diamond Textured, Medium, Inner Pack
• 00850048574601: Nitrile Gloves, Exam Grade, Powder Free, Orange, Full Diamond Textured, Small, Inner Pack
• 00840369314192: Blue Nitrile Glove, Exam Grade, Powder Free, Finger Textured, Pre Packaged, Large, 1000/case