Saniflex

GUDID 26973163407116

Guangdong KINGFA SCI.&TECH. Co., Ltd.

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

• Primary Device ID: 26973163407116
• NIH Device Record Key: 79708aff-e67c-47b6-90fc-ed552996b477
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Saniflex
• Version Model Number: KF-B P05(L3)
• Company DUNS: 543265548
• Company Name: Guangdong KINGFA SCI.&TECH. Co., Ltd.
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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
GS1	06973163407112 [Unit of Use]
GS1	16973163407119 [Primary]
GS1	26973163407116 [Package]; Contains: 16973163407119; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202139

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: 2021-10-20
• Device Publish Date: 2021-10-12

Devices Manufactured by Guangdong KINGFA SCI.&TECH. Co., Ltd.

• 26975390737714 - MAADHO: 2023-03-24 nitrile examination gloves large size
• 26975390734973 - KINGFA: 2023-02-22 nitrile examination gloves small size
• 26975390735017 - KINGFA: 2023-02-22 nitrile examination gloves small size
• 26975390736724 - M TRACK: 2023-02-20 nitrile exam gloves small size
• 26975390736731 - M TRACK: 2023-02-20 nitrile exam gloves medium size
• 26975390736748 - M TRACK: 2023-02-20 nitrile exam large size
• 26975390736755 - M TRACK: 2023-02-20 nitrile exam gloves extra large size
• 26973163407116 - Saniflex: 2021-10-20
• 26973163407116 - Saniflex: 2021-10-20