Makrite Industries Inc.

GUDID 06973875280775

FDA cleared ASTM Level 3 earloop surgical face mask, regular size.

Makrite Hubei Industrial Co., Ltd.

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

• Primary Device ID: 06973875280775
• NIH Device Record Key: 952bb95f-9376-470f-bcb4-d6eea2369f81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Makrite Industries Inc.
• Version Model Number: M663BE
• Company DUNS: 553815471
• Company Name: Makrite Hubei Industrial 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973875280775 [Primary]
GS1	16973875280772 [Package]; Package: case [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220550

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: 2023-07-24
• Device Publish Date: 2023-07-14

On-Brand Devices [Makrite Industries Inc.]

• 06973875280089: NIOSH approved and FDA cleared foldable N95 disposable respirator, regular size.
• 06973875281000: NIOSH approved and FDA cleared cone style N95 disposable respirator, medium and large size.
• 16973875280789: FDA cleared ASTM level 3 tie-on surgical pleated face mask, regular size.
• 06973875280775: FDA cleared ASTM Level 3 earloop surgical face mask, regular size.
• 06973875280072: NIOSH approved and FDA cleared duckbill style N95 disposable respirator, regular size.
• 06973875281017: NIOSH approved and FDA cleared cone style N95 disposable respirator, adult small size.
• 16973875280765: NIOSH approved and FDA cleared cone style N95 disposable respirator, adult small size.
• 16973875280758: NIOSH approved and FDA cleared cone style N95 disposable respirator, medium/large size.
• 16973875280741: NIOSH approved and FDA cleared 3-panel foldable N95 disposable respirator, regular size.