GoodFeeling Medical Surgical Mask (non-sterile)

GUDID 06973078400130

The medical surgical masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

Foshan GoodFeeling Hygiene Material Tec Co., Ltd.

Surgical/medical face mask, single-use

• Primary Device ID: 06973078400130
• NIH Device Record Key: e5162442-d49b-4be2-8cca-ff16d8acdfdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GoodFeeling Medical Surgical Mask (non-sterile)
• Version Model Number: GFYY95
• Company DUNS: 551102789
• Company Name: Foshan GoodFeeling Hygiene Material Tec Co., Ltd.
• Device Count: 50
• 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	06973078400130 [Unit of Use]
GS1	06973078400208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202761

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: 2021-05-17
• Device Publish Date: 2021-05-07

Devices Manufactured by Foshan GoodFeeling Hygiene Material Tec Co., Ltd.

• 06973078400147 - GoodFeeling Disposable Medical Face Mask (non-sterile): 2021-05-17
• 06973078400130 - GoodFeeling Medical Surgical Mask (non-sterile): 2021-05-17The medical surgical masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
• 06973078400130 - GoodFeeling Medical Surgical Mask (non-sterile): 2021-05-17 The medical surgical masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microor