S&J

GUDID 16974960067100

Disposable Medical Face Mask Level 2, Ear-loop, 17.5*9.5cm

Xiantao S&J Protective Products Co., Ltd

Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use

• Primary Device ID: 16974960067100
• NIH Device Record Key: cc3c1fc4-4113-492f-9107-9e6aa3177426
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S&J
• Version Model Number: M1710
• Company DUNS: 554445746
• Company Name: Xiantao S&J Protective Products 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: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	16974960067100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211462

FDA Product Code

• FXX: Mask, Surgical

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: 2022-04-06
• Device Publish Date: 2022-03-29

On-Brand Devices [S&J]

• 06974960061132: M2213
• 16974960067100: Disposable Medical Face Mask Level 2, Ear-loop, 17.5*9.5cm
• 06974960067103: Disposable Medical Face Mask Level 2, Ear-loop, 17.5*9.5cm
• 16974960062235: Disposable Medical Face Mask Level 2 (Non-Sterile)
• 06974960062238: Disposable Medical Face Mask Level 2 (Non-Sterile)
• 16974960066110: PP ISOLATION GOWN