K092580 · Tidi Products,Llc · FXX · Feb 23, 2010 · General, Plastic Surgery
Device Facts
Record ID
K092580
Device Name
TIDI FACEMASK
Applicant
Tidi Products,Llc
Product Code
FXX · General, Plastic Surgery
Decision Date
Feb 23, 2010
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4040
Device Class
Class 2
Indications for Use
Surgical mask are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of micro-organisms, body fluids and particulate material.
Device Story
TIDI Facemask is a non-sterile, pleated, multi-ply surgical mask. Construction includes outer and inner layers of spun-bound polypropylene and a melt-blown polypropylene filter media. Features include malleable aluminum nosepiece and latex-free elastic ear loops; some models include polyester urethane foam anti-fog strip. Device is worn by operating room personnel over nose and mouth to provide a physical barrier against microorganisms, body fluids, and particulates. Intended for use in surgical settings to protect both patient and wearer.
Clinical Evidence
Bench testing only. Performance evaluated against ASTM F 2100-07 standards. Results: Bacterial Filtration Efficiency >99.9% (ASTM 2101); Differential Pressure 3.4 mm H2O/cm² (MIL-M 36954C); Sub-micron Particulate Filtration Efficiency 99.6% (ASTM F 2299); Synthetic blood penetration resistance passed at 80 mmHg (ASTM F 1862); Flammability Class 1 (16CFR Part 1610).
Indicated for operating room personnel to protect the surgical patient and personnel from transfer of microorganisms, body fluids, and particulate material during surgical procedures.
Regulatory Classification
Identification
Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.
Special Controls
*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows a logo for TIDL Products. The logo features a stylized letter "T" with swooping lines above it. Below the "T" is the word "TIDL" in bold, followed by "PRODUCTS" in a smaller font. The tagline "Care with Confidence" is written in a cursive font below the main text.
Certified in 190 9001:2000, EN/ISO 13485:2003, European CE Mark
K092580
# 510(k) Summary TIDI® Facemask
FEB 2 8 2010
#### To: Whom it may concern
Date: February 12, 2010
#### Submitter/ Contact - Name and Address
Dion J. Brandt Quality Manager TIDI Products, LLC 570 Enterprise Drive Neenah WI 54956 Telephone: (920) 751-4386 (920) 751-4370 Fax:
#### FDA Registration Number: 2182318
#### Device Details:
Trade Name: TIDI® Facemasks or Customer trade names Common Name: Surgical Mask Classification Name: Mask, Surgical Product Code: FXX Regulation Number: 878.4040
### Equivalent Legally Marketed Device:
The TIDI® Facemasks are similar to the predicate device in material composition, design, style and dimensions. The similarities in materials, design, style along with performance testing supports that the TIDI® Facemasks are substantially equivalent to the predicate device. The comparison table on the following page out-lines the similarities and any differences between the TIDI® Facemask and the predicate device.
{1}------------------------------------------------
K092580
### Predicate Devices
1) A.R. Medicom Non-Sterile Surgical Mask 2) Crosstex Isolite Surgical Mask
.
510 K Number: K051291 K012602
| Description | TIDI® Facemask | Predicate:<br>Non-Sterile Surgical Mask<br>K051291 and K012602 |
|----------------|--------------------------|----------------------------------------------------------------|
| Materials | | |
| Outer layer | Polypropylene Spun-bond | Same |
| Filter Media | Melt-blown polypropylene | Same |
| Inner Layer | Polypropylene Spun-bond | Same |
| Nose Piece | Malleable aluminum | Same |
| Ear Attachment | Elastic | Same |
| Anti-Fog | Foam | N/A |
| Dimensions | | |
| Length | 7.0 inches | Same |
| Width | 3.5 inches | Same |
| Design | | |
| Style | Flat, Pleated | Same |
| | Fluid resistant | Same |
| | Elastic Ear loops | Same |
| Sterile | No | Same |
{2}------------------------------------------------
# DESCRIPTION OF THE DEVICE:
The TIDI® Facemask, are pleated multi-ply design which are supplied non sterile. The outer layers are made of 100% spun-bound polypropylene (SBPP). The filter media is composed of 100% melt-blown polypropylene (MBPP). The inner layer is made of either 100% SBPP or 100% medical grade tissue paper. The ear loops are made of latex free elastic. The nosepieces are made of malleable aluminum, and can be supplied with an anti fog strip made of polyester urethane foam. All materials used in the construction of the mask are being used in currently marketed devices. The mask covers the nose and mouth, and is secured to the face using the attached ear loops. The TIDI® Facemasks are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of microorganisms, body fluids and particulate material.
K092580
The following is a list of models of the TIDI® Facemasks with a description.
Model 9010 -This is the standard facemask model with ear loop attachments.
Model 9020-This facemask model is supplied with an anti-fog strip of polyurethane foam. The foam is attached over the nose wire on the inside of the mask.
# INTENDED USE:
The TIDI® Facemask intended use is: Surgical mask are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of micro-organisms, body fluids and particulate material.
Page 3 of 5
{3}------------------------------------------------
K092580
# Device and Predicate Device Technical Characteristics:
| Description | TIDI® | Predicate Device | Predicate Device | | | | | |
|-----------------------------------------------------------------------------------|---------------|---------------------|---------------------|--|--|--|--|--|
| | Facemask | K012602 | K051291 | | | | | |
| | | Crosstex® Ultra | Safe+Mask® Premier | | | | | |
| | | Fluid Resistant No- | Elite Ear loop Mask | | | | | |
| | | Fog® Ear Loop Face | | | | | | |
| | | Mask | | | | | | |
| Material Composition | | | | | | | | |
| Type of fabric: | | | | | | | | |
| Outer Layer | Polypropylene | Polypropylene | Polypropylene | | | | | |
| | Spun-bond | Spun-bond | Spun-bond | | | | | |
| Filter Media | Melt-blown | Melt-blown | Melt-blown | | | | | |
| | polypropylene | polypropylene | polypropylene | | | | | |
| Inner Layer | Polypropylene | Polypropylene | Polypropylene | | | | | |
| | Spun-bond | Spun-bond | Spun-bond | | | | | |
| Other Materials: | | | | | | | | |
| Nose Piece: | Aluminum | Aluminum | Aluminum | | | | | |
| Lar | Elastic | Elastic | Elastic | | | | | |
| Attachment: | | | | | | | | |
| Anti-Fog | Polyester | Polyester Urethane | none | | | | | |
| | Urethane foam | foam | | | | | | |
| The difference of the anti fog material is the polyester urethane foam. The | | | | | | | | |
| polyester foam material has been used in medical application on facemask for | | | | | | | | |
| an anti-fog strip without any toxicity or biological compatibility issues. It has | | | | | | | | |
| been proven to be non-toxic, non-sensitizing, and non-irritating. | | | | | | | | |
| Specification and Dimensions: | | | | | | | | |
| Dimensions: | | | | | | | | |
| Length: | 7.0 inches | 7.0 inches | 7.0 inches | | | | | |
| | | | | | | | | |
| Width: | 3.5 inches | 3.5 inches | 3.5 inches | | | | | |
| Design | Ear Loop | Ear Loop | Ear Loop | | | | | |
| Features: | | | | | | | | |
| Mask Style: | Flat Pleated | Flat Pleated | Flat Pleated | | | | | |
| | | | | | | | | |
Page 4 of 5
{4}------------------------------------------------
K092580
# Nonclinical Tests Performed for Determination of Substantial Equivalents are as Follows:
The following is a list of test methods for the TIDI® Facemask in accordance with ASTM 2100 specification for surgical masks. It was our conclusion that testing was conducted and met the specified acceptance criteria of ASTM F 2100-07 Standard Specification for Performance of Materials Used in Medical Face Mask.
| | Face Mask Requirements by<br>Performance Class (ASTM F 2100-07) | | | |
|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------|--------------|-------------------------------------------|
| Performance Characteristics | Low<br>Barrier | Moderate<br>Barrier | High Barrier | TIDI® Facemask<br>Test Results<br>Summary |
| Bacterial Filtration Efficiency<br>Performance (%) (ASTM<br>2101) | ≥95 | ≥98 | ≥98 | >99.9 |
| Differential Pressure (Delta-P)<br>(mm H2O/cm²) (MIL-M<br>36954C) | <4.0 | <4.0 | <4.0 | 3.4 |
| Sub-micron Particulate<br>Filtration Efficiency at 0.1<br>micron Performance (%)<br>(ASTM F 2299) | Not<br>required | ≥98 | ≥98 | 99.6 |
| Resistance to penetration by<br>synthetic blood, Minimum<br>pressure in mmHg for pass<br>results. (ASTM F 1862) | 80 | 120 | 160 | Pass<br>@ 80 mm Hg |
| Flammability Class<br>(16CFR Part 1610) | Class 1 | Class 1 | Class 1 | Class 1 |
# Conclusion:
The TIDI® Facemask has the same intended use and technological characteristics as the predicate devices. Product testing and FMEA risk analysis performed did not identify any other risks on the safety or effectiveness associated with surgical masks, other then identified in the Guidance for Industry and FDA Staff: Surgical Masks- Premarket Notification [510(k)] Submission: Guidance for Industry and FDA issued on: March 5, 2004. The TIDI® Facemask are substantially equivalent to the predicate device.
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized human figure with three arms reaching upwards, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Ms. Dion J. Brandt Quality Manager TIDI Products, LLC 570 Enterprise Drive Neenah, Wisconsin 54956
FEB 2 8 2010 -
Re: - K092580 Trade/Device Name: TIDI® Facemask Regulation Number: 21CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: December 7, 2009 Received: December 7, 2009
Dear Ms. Brandt:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act-(Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{6}------------------------------------------------
Page 2- Ms. Brandt
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sean Runser
Anthony D. Watson, BS, MS, MBA Director
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
#### Enclosure
{7}------------------------------------------------
Kogas 80
# Medical Devices
# Indications for Use Form
#### Indications for Use
510(K) Number (if Known): K092580
Device Name: TIDI® Facemask
Surgical mask are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of micro-organisms, body fluids and particulate material.
Prescription use (Part 21 CFR 801 Subpart D) AND/OR Over- The Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elijabeth F. Slaviero Wills
(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices
510(k) Number: K092580
Predicate graph will load when search results are available.
Embedding visualization will load when search results are available.
PDF viewer will load when search results are available.
Loading panels...
Select an item from Submissions
Click any panel, subpart, regulation, product code, or device to see details here.
Section Matches
Results will appear here.
Product Code Matches
Results will appear here.
Special Control Matches
Results will appear here.
Loading collections...
Loading
My Alerts
You will receive email notifications based on the filters and frequency you set for each alert.
Sort by:
Create Alert
Search Filters
Agent Token
Create a read-only bearer token for Claude, ChatGPT, or other agents that can call HTTP APIs.
Copy this now. It will not be shown again.
Connected apps
Apps you authorized through browser sign-in. Disconnecting revokes their access immediately.
Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
