Gloveworks

GUDID 00697383916105

Box

AMMEX CORPORATION

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: 00697383916105
• NIH Device Record Key: b16ca09c-b8cc-46cc-b7de-62d43beb2706
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gloveworks
• Version Model Number: GPLHD84100
• Company DUNS: 187070768
• Company Name: AMMEX CORPORATION
• Device Count: 1
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00697383916105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000999

FDA Product Code

• LYY: Latex Patient Examination Glove
• 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: 2022-08-01
• Device Publish Date: 2022-07-22

On-Brand Devices [Gloveworks]

• 00697383973573: Case
• 00697383973566: Case
• 00697383973559: Case
• 00697383973542: Case
• 00697383973535: Case
• 00697383973511: Box
• 00697383973504: Box
• 00697383973498: Box
• 00697383973481: Box
• 00697383973474: Box
• 00697383916655: Case
• 00697383916549: Case
• 00697383916433: Case
• 00697383916327: Box
• 00697383916211: Box
• 00697383916105: Box
• 00697383413642: Case
• 00697383413635: Case
• 00697383413628: Case
• 00697383403643: Box
• 00697383403636: Box
• 00697383403629: Box
• 20697383973607: Sample Case
• 20697383968658: Sample Case
• 20697383968610: Sample Case
• 10697383973594: Master Bag
• 10697383968651: Master Bag
• 10697383968613: Master Bag
• 00697383975904: pallet of 60
• 00697383975898: pallet of 60
• 00697383975881: pallet of 60
• 20697383978435: Sample Case
• 10697383978438: Sample Box
• 20697383978503: Sample Case
• 10697383978506: Sample Box