Examination gloves – Type C (Nitrile gloves)

GUDID 26972267280151

Powder-free textured; The packages of proposed device including middle box package and outer carton package. Middle box package quantity: 100PCS Outer carton package quantity: 1000PCS

Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.

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: 26972267280151
• NIH Device Record Key: 5ff4ecbd-355b-4461-a9c5-1e5ec843f32d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Examination gloves – Type C (Nitrile gloves)
• Version Model Number: S
• Company DUNS: 421353735
• Company Name: Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972267280157 [Unit of Use]
GS1	16972267280154 [Primary]
GS1	26972267280151 [Package]; Contains: 16972267280154; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212290

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: 2022-08-02
• Device Publish Date: 2022-07-25

On-Brand Devices [Examination gloves – Type C (Nitrile gloves)]

• 26972267280182: Powder-free textured; The packages of proposed device including middle box package and outer car
• 26972267280175: Powder-free textured; The packages of proposed device including middle box package and outer car
• 26972267280168: Powder-free textured; The packages of proposed device including middle box package and outer ca
• 26972267280151: Powder-free textured; The packages of proposed device including middle box package and outer ca