Procedure Mask 3 ply level 1, color 50 per box, BLACK

GUDID B958FM3881

Procedure Mask 3 ply level 1, color 50 per box color black

Excel Gloves & Safety Supplies, Inc.

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

• Primary Device ID: B958FM3881
• NIH Device Record Key: 5ff3243e-49d1-4849-91a0-5a4eebe08a09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procedure Mask 3 ply level 1, color 50 per box, BLACK
• Version Model Number: FM BLACK
• Company DUNS: 928913409
• Company Name: Excel Gloves & Safety Supplies, Inc.
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B958FM3881 [Unit of Use]
HIBCC	B958FM388BLK1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202708

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: 2024-09-16
• Device Publish Date: 2024-09-06

Devices Manufactured by Excel Gloves & Safety Supplies, Inc.

• B958FM3881 - Procedure Mask 3 ply level 1, color 50 per box, BLACK: 2024-09-16Procedure Mask 3 ply level 1, color 50 per box color black
• B958FM3881 - Procedure Mask 3 ply level 1, color 50 per box, BLACK: 2024-09-16 Procedure Mask 3 ply level 1, color 50 per box color black
• B958FM388G1 - EXCEL Procedure Mask 3 ply level 1, 50 per box, mint green: 2024-09-16 PROCEDURE MASK 3 PLY LEVEL 1 MINT GREEN, 50 PER BOX
• B9584886 - ICON: 2023-08-10 GLOVES, EXAMINATION POWDER FREE EXAM TEXTURED SMALL ICON4886
• B958E2086 - EXCEL: 2023-08-10 GLOVES VINYL EXAMINATION POWDER FREE SMALL E2086
• B958E2087 - EXCEL: 2023-08-10 GLOVES VINYL EXAMINATION POWDER FREE MEDIUM E2087
• B958E2088 - EXCEL: 2023-08-10 GLOVES VINYL EXAMINATION POWDER FREE LARGE E2088
• B958EM1887 - EXCEL: 2023-08-10 GLOVES EXAMINATION POWDER-FREE TEXTURED FENTANYL TSTED BLUE EM1887 MEDIUM
• B958EM1888 - EXCEL: 2023-08-10 GLOVES, EXAMINATION POWDER-FREE TEXTURED, FENTANYL TESTED BLUE EM1888 LARGE