Disposable Sterilized Latex Surgical Gloves

GUDID 16972267280116

Powder-free textured; The packages of proposed device including immediate package, middle box package and outer carton package. Immediate package quantity: 1 pair Middle box package quantity: 50 pairs Outer carton package quantity: 400 pairs

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

Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial Hevea-latex surgical glove, non-powdered, non-antimicrobial

• Primary Device ID: 16972267280116
• NIH Device Record Key: 40389d17-2597-43c5-bb01-a7627a7b34d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Sterilized Latex Surgical Gloves
• Version Model Number: 7
• Company DUNS: 421353735
• Company Name: Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972267280119 [Primary]
GS1	16972267280116 [Package]; Contains: 06972267280119; Package: [50 Units]; In Commercial Distribution
GS1	26972267280113 [Package]; Contains: 06972267280119; Package: [400 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211953

FDA Product Code

• KGO: Surgeon'S Gloves

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-26
• Device Publish Date: 2022-07-18

On-Brand Devices [Disposable Sterilized Latex Surgical Gloves]

• 16972267280000: Powder-free textured; The packages of proposed device including immediate package, middle box pa
• 16972267280147: Powder-free textured; The packages of proposed device including immediate package, middle box p
• 16972267280130: Powder-free textured; The packages of proposed device including immediate package, middle box p
• 16972267280123: Powder-free textured; The packages of proposed device including immediate package, middle box p
• 16972267280116: Powder-free textured; The packages of proposed device including immediate package, middle box pa
• 16972267280109: Powder-free textured; The packages of proposed device including immediate package, middle box pa