Examination gloves – Type A (Latex gloves)

GUDID 26972267280359

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: 2000PCS

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

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

• Primary Device ID: 26972267280359
• NIH Device Record Key: 1ca237b8-3394-4363-9f2a-2786013b4f70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Examination gloves – Type A (Latex gloves)
• Version Model Number: XL
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972267280355 [Unit of Use]
GS1	16972267280352 [Primary]
GS1	26972267280359 [Package]; Contains: 16972267280352; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K214017

FDA Product Code

• LYY: Latex 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: 2022-08-18
• Device Publish Date: 2022-08-10

On-Brand Devices [Examination gloves – Type A (Latex gloves)]

• 26972267280359: Powder-free textured; The packages of proposed device including middle box package and outer car
• 26972267280335: Powder-free textured; The packages of proposed device including middle box package and outer ca
• 26972267280328: Powder-free textured; The packages of proposed device including middle box package and outer ca
• 26972267280311: Powder-free textured; The packages of proposed device including middle box package and outer ca