RISERVA BASNGPF3004

GUDID G378BASNGPF30042

RISERVA NITRILE EXAMINATION GLOVES XLARGE BOX OF 180

Mohawk Hospital Equipment, Inc.

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

• Primary Device ID: G378BASNGPF30042
• NIH Device Record Key: aa9121b5-7ff8-4060-ac87-7f6feea3bac0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RISERVA
• Version Model Number: BASNGPF30042
• Catalog Number: BASNGPF3004
• Company DUNS: 013326384
• Company Name: Mohawk Hospital Equipment, Inc.
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G378BASNGPF30042 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110981

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: 2023-03-20
• Device Publish Date: 2023-03-10

On-Brand Devices [RISERVA]

• G378BASNGPF30012: RISERVA NITRILE EXAMINATION GLOVES SMALL BOX OF 200
• G378BASVGPF40042: RISERVA VINYL EXAMINATION GLOVES XLARGE BOX OF 150
• G378BASVGPF40041: RISERVA VINYL EXAMINATION GLOVES XLARGE CASE OF 1500
• G378BASVGPF40032: RISERVA VINYL EXAMINATION GLOVES LARGE BOX OF 150
• G378BASVGPF40031: RISERVA VINYL EXAMINATION GLOVES LARGE CASE OF 1500
• G378BASVGPF40022: RISERVA VINYL EXAMINATION GLOVES MEDIUM BOX OF 150
• G378BASVGPF40021: RISERVA VINYL EXAMINATION GLOVES MEDIUM CASE OF 1500
• G378BASVGPF40012: RISERVA VINYL EXAMINATION GLOVES SMALL BOX OF 150
• G378BASVGPF40011: RISERVA VINYL EXAMINATION GLOVES SMALL CASE OF 1500
• G378BASNGPF30042: RISERVA NITRILE EXAMINATION GLOVES XLARGE BOX OF 180
• G378BASNGPF30041: RISERVA NITRILE EXAMINATION GLOVES XLARGE CASE OF 1800
• G378BASNGPF30032: RISERVA NITRILE EXAMINATION GLOVES LARGE BOX OF 200
• G378BASNGPF30031: RISERVA NITRILE EXAMINATION GLOVES LARGE CASE OF 2000
• G378BASNGPF30022: RISERVA NITRILE EXAMINATION GLOVES MEDIUM BOX OF 200
• G378BASNGPF30021: RISERVA NITRILE EXAMINATION GLOVES MEDIUM CASE OF 2000
• G378BASNGPF30011: RISERVA NITRILE EXAMINATION GLOVES SMALL CASE OF 2000