Top Quality Manufacturing

GUDID TQ26FM2180310

TQMPL Face Mask - ASTM 1 - Purple / Lavender - New

TOP QUALITY MANUFACTURING, INC.

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

• Primary Device ID: TQ26FM2180310
• NIH Device Record Key: 6bd8c49f-323b-4f1f-b856-7aacc9eadacf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Top Quality Manufacturing
• Version Model Number: FM2-1803
• Company DUNS: 113630649
• Company Name: TOP QUALITY MANUFACTURING, 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)483-8559
• Email: regulatory@topqualitygloves.com
• Phone: +1(800)483-8559
• Email: regulatory@topqualitygloves.com
• Phone: +1(800)483-8559
• Email: regulatory@topqualitygloves.com
• Phone: +1(800)483-8559
• Email: regulatory@topqualitygloves.com
• Phone: +1(800)483-8559
• Email: regulatory@topqualitygloves.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	TQ26FM2180310 [Unit of Use]
HIBCC	TQ26FM2180311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221838

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: 2024-12-17
• Device Publish Date: 2024-12-09

On-Brand Devices [Top Quality Manufacturing]

• TQ26126031120: Standard Carbide Bur - Pear - 331 - FG
• TQ26126031110: Standard Carbide Bur - Pear - 330 - FG ShortShank
• TQ26126031100: Standard Carbide Bur - Pear - 330 - FG
• TQ26126031090: Standard Carbide Bur - Round - 8 - FG
• TQ26126031080: Standard Carbide Bur - Round - 6 - FG
• TQ26126031070: Standard Carbide Bur - Round - 4 - FG
• TQ26126031060: Standard Carbide Bur - Round - 2 - FG
• TQ26126031050: Standard Carbide Bur - Round - 1/2 - FG
• TQ26126031040: Standard Carbide Bur - Round - 1/4 - FG
• TQ26126031030: Standard Carbide Bur - Pear - 2P - FG
• TQ26126031020: Standard Carbide Bur - Pear - 1P - FG
• TQ26126031010: Standard Carbide Bur - EndoSafe End - Plain - ESE014 - FG
• TQ26126034420: TQMPL Diamonds - Zirconia / Ceramic Cutters - GWZ 801-018
• TQ26126034410: TQMPL Diamonds - Zirconia / Ceramic Cutters - GWZ 801-014
• TQ26126034400: TQMPL Diamonds - Zirconia / Ceramic Cutters - GWZ 856-018
• TQ26126034390: TQMPL Multi Use Diamond - KS - KS2-SC - Super Coarse
• TQ26126034380: TQMPL Multi Use Diamond - KS - KS1-SC-S - Super Coarse - Short Shank
• TQ26126034370: TQMPL Multi Use Diamond - KS - KS1-SC - Super Coarse
• TQ26126034350: TQMPL Multi Use Diamond - KS - KS0-M - Medium
• TQ26126034310: TQMPL Multi Use Diamond - Micro Prep Fissurotomy - Original F - Fine
• TQ26126034300: TQMPL Multi Use Diamond - Micro Prep Fissurotomy - Original M - Medium
• TQ26126034290: TQMPL Multi Use Diamond - Wheel - 909-042SC - Super Coarse
• TQ26126034280: TQMPL Multi Use Diamond - Wheel - 909-042C - Coarse
• TQ26126034270: TQMPL Multi Use Diamond - Wheel - 909-036C - Coarse
• TQ26126034250: TQMPL Multi Use Diamond - Acorn - 905-027M-S - Medium - Short Shank
• TQ26126034230: TQMPL Multi Use Diamond - Acorn - 905-023M-S - Medium - Short Shank
• TQ26126034220: TQMPL Multi Use Diamond - Acorn - 905-023F-S - Fine - Short Shank
• TQ26126034210: TQMPL Multi Use Diamond - Acorn - 905-018M-S - Medium - Short Shank
• TQ26126034200: TQMPL Multi Use Diamond - Round End Cylinder - 881-014C - Coarse
• TQ26126034190: TQMPL Multi Use Diamond - Curettage - 878K-016SC-S - Super Coarse - Short Shank
• TQ26126034180: TQMPL Multi Use Diamond - Curettage - 878K-014M - Medium
• TQ26126034170: TQMPL Multi Use Diamond - Modified Beveled Cylinder - 878-012SC - Super Coarse
• TQ26126034160: TQMPL Multi Use Diamond - Flame - 863-012F - Fine
• TQ26126034150: TQMPL Multi Use Diamond - Flame - 863-012C - Coarse
• TQ26126034130: TQMPL Multi Use Diamond - Flame - 862-014M - Medium
• TQ26126034120: TQMPL Multi Use Diamond - Flame - 862-012SC - Super Coarse
• TQ26126034110: TQMPL Multi Use Diamond - Flame - 862-012F - Fine
• TQ26126034100: TQMPL Multi Use Diamond - Flame - 862-012C - Coarse
• TQ26126034090: TQMPL Multi Use Diamond - Needle - 859-016F - Fine
• TQ26126034080: TQMPL Multi Use Diamond - Needle - 859-014C - Coarse
• TQ26126034070: TQMPL Multi Use Diamond - Needle - 859-010M - Medium
• TQ26126034060: TQMPL Multi Use Diamond - Needle - 859-010F - Fine
• TQ26126034050: TQMPL Multi Use Diamond - Needle - 858-012M - Medium
• TQ26126034040: TQMPL Multi Use Diamond - Needle - 858-012F - Fine
• TQ26126034030: TQMPL Multi Use Diamond - Round End Taper Long - 856L-018SC - Super Coarse
• TQ26126034020: TQMPL Multi Use Diamond - Round End Taper Long - 856L-016SC - Super Coarse
• TQ26126034010: TQMPL Multi Use Diamond - Round End Taper - 856-025SC - Super Coarse
• TQ26126034000: TQMPL Multi Use Diamond - Round End Taper - 856-021C - Coarse
• TQ26126033990: TQMPL Multi Use Diamond -Round End Taper- 856-018SC-S - SuperCoarse - ShortShank
• TQ26126033980: TQMPL Multi Use Diamond - Round End Taper - 856-018C-S - Coarse - Short Shank