SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN
K022256 · Tucker & Associates · FXX · Apr 26, 2004 · General, Plastic Surgery
Device Facts
Record ID
K022256
Device Name
SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN
Applicant
Tucker & Associates
Product Code
FXX · General, Plastic Surgery
Decision Date
Apr 26, 2004
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4040
Device Class
Class 2
Indications for Use
This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.
Device Story
Non-sterile surgical face mask available in white, yellow, pink, blue, and green. Designed for use by healthcare professionals, dentists, and emergency responders in clinical settings. Acts as physical barrier to reduce transfer of microorganisms, body fluids, and particulates between wearer and environment. Performance verified through standardized testing for fluid resistance, bacterial filtration efficiency, and flammability. Intended to protect both patient and personnel.
Clinical Evidence
Bench testing only. Performance metrics: Fluid resistance (ASTM F-1862-00a) passed with no visual penetration; Bacterial Filtration Efficiency (ASTM F-2101-01) 97.9%; Differential Pressure (MIL M 36945C4.4.1.1.1) 1.8; Flammability (16 CFR 1610) Class 2. Biocompatibility and Agar Diffusion tests successfully completed.
Technological Characteristics
Non-sterile surgical face mask. Materials tested per ASTM F2299-03. Fluid resistance per ASTM F1862-00a. BFE per ASTM F2101-01. Differential pressure per MIL M 36945C4.4.1.1.1. Flammability per 16 CFR 1610.4 (Class 2). Biocompatible materials.
Indications for Use
Indicated for use by healthcare personnel and patients to provide a barrier against microorganisms, body fluids, and particulate material.
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.
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APR 2 6 2004
# 510(k) SUMMARY K022256
| Submitted For: | TUCKER & ASSOCIATES<br>198 Ave. de la D'emerald<br>Sparks, Nevada 89434-9550 |
|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by: | JANNA P. TUCKER, President - CEO<br>And Official Correspondent for<br>Tucker & Associates<br>198 Avenue de la D'emerald<br>Sparks, NV 89434<br>Phone: 775-342-2612<br>Fax: 775-342-2613<br>E-mail: Tuckerjan@aol.com |
| Date of Submission: | Original: 12 July 2002, "Add to File" revisions and<br>additions 2 April 2004 |
| Classification Name: | Surgical Face Mask, FXX, Class 2 Device |
| Proprietary Name:<br>Common Name:<br>Regulatory Reference:<br>Predicate Device: | (Multiple Labels)<br>Face Mask, Surgical<br>21 CFR 878.<br>Face Mask, Surgical Mask, K970835 |
| Labels/Labeling: | This device will be marketed to medical device suppliers,<br>Dentist and Doctor Offices, Clinics, Emergency Response<br>Professionals, Hospitals and other healthcare professionals<br>for the Intended Use purposes below. |
| Intended Use: | This device is intended to be worn to protect both the<br>patient and healthcare personnel from transfer of<br>microorganisms, body fluids and particulate material. |
| Description: | Non-sterile surgical face mask, white, yellow, pink, blue<br>and green. |
| Substantial Equivalence: | This device is equivalent to one in commercial distribution<br>approved K970835, but specifically, and most importantly,<br>it has passed all recommended standards and/or tests as<br>follows: |
| | |
| | Standards and/or tests: |
| ASTM F2299-03 | ...materials used in Face Masks |
| ASTM F1862-00a | ...Resistance of Medical Face Masks to Penetration |
| | By Synthetic Blood |
| | ASTM F2101-01 |
| | Medical Face Mask Materials. |
| | MIL M 36945C4.4.1.1.1 |
| 15 CFR 1610.4 | Flammability Class - tested at flammability Class 2 |
| | Biocompatibility and Agar Diffusion Tests successfully completed. |
EXHIBIT J
Page 73 of 88
Revised 04-02-04
gk
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Page 2, 510(k) Summary K022256
#### Performance Characteristics Test Method Acceptance Criteria/Results
| Fluid Resistance Performance | ASTM F-1862-00a | No visual detection of penetration |
|----------------------------------------------------------|-----------------------|------------------------------------|
| Filter Efficiency Performance | 2.0 Microns | Passed 2.0 Micron Test |
| Bacterial Filtration Efficiency<br>Performance (%) (BFE) | ASTM F-2101-01 | Passed at 97.9% |
| Differential Pressure (Delta-P) | MIL M 36945C4.4.1.1.1 | Passed at 1.8 |
| Flammability Class | 16 CFR 1610 | Passed at Flammability Class 2 |
## EQUIVALENCY COMPARISONS:
| | | Current Device |
|-----------------------------------------|-----------------|-----------------------|
| | K970835 | K022256 |
| Fluid Resistance | Fluid Resistant | No visual penetration |
| Filter Efficiency Performance (microns) | 2.9 microns | 2.0 microns |
| BFE % | 96.4% | 97.9% |
| Delta-P | 1.7 | 1.8 |
| Flammability Class | 3 | 2 |
Conclusion:
This device is substantially equivalent to the device approved as K970835
EXHIBIT J
Page 74 of 88
Revised 04-02-04
gt.
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### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the seal is a symbol that looks like three stylized waves or lines.
#### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 6 2004
Tucker & Associates Ms. Janna Tucker Official Correspondents 198 Avenue De La D' Emerald Sparks, Nevada 89434-9550
Re: K022256
Trade/Device Name: Surgical Face Mask Colors: White, Yellow, Pink, Blue and Green Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: April 2, 2004 Received: April 6, 2004
Dear Ms. Tucker:
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 such 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.
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Page 2 - Ms. Tucker
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97), 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Carls
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
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## INDICATIONS FOR USE
## TUCKER AND ASSOCIATES APPLICANT: -KO22256 510(k) NUMBER:
## DEVICE NAME: SURGICAL FACE MASK Colors: White, Yellow, Pink, Blue And Green
This device is intended to be worn to protect both the patient and healthcare personnel From transfer of microorganisms, body fluids and particulate material
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kevin Mulvey
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K022254
Page 1 of
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.
