K992445 · Kappler USA · FYA · Feb 18, 2000 · General, Plastic Surgery
Device Facts
Record ID
K992445
Device Name
MED-GUARD SURGEON'S GOWN
Applicant
Kappler USA
Product Code
FYA · General, Plastic Surgery
Decision Date
Feb 18, 2000
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4040
Device Class
Class 2
Indications for Use
The gown is intended to protect the wearer from blood and other body fluids encountered during surgery
Device Story
Med-Guard surgical gown; tri-layer composite material (spunbonded polypropylene/meltblown polypropylene/spunbonded polypropylene); treated with anti-static agent. Used in surgical settings to protect wearer from blood and body fluids. Device provides physical barrier; tested for hydrostatic pressure resistance, bacterial filtration efficiency, moisture vapor transmission, flammability, and physical strength (bursting, breaking, tear). Sterilized via 100% ETO. No software or algorithm involved.
Clinical Evidence
No clinical performance data; clinical testing was limited to biocompatibility and safety of the anti-static treatment. Testing included Acute Systemic Toxicity (Hemolysis), Cytotoxicity (MEM Emulsion), and Delayed Contact Sensitization. Non-clinical bench testing included Hydrostatic Pressure Resistance (ASTM D 751), Bacterial Filtration Efficiency (MIL-M-36954C), Moisture Vapor Transmission (ASTM E 96), Flammability (NFPA 702), and physical strength testing (ASTM D 751, ASTM D 5733).
Indicated for use by surgical personnel to protect the wearer from blood and other body fluids encountered during surgery.
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}------------------------------------------------
K992445
## 510(k) Summary
- Kappler USA, Inc. a (1) PO Box 218 Guntersville, AL 35976
Contact: Philip Mann (256) 205-4146
Prepared: August 18, 1999
- a (2) Device Name: Surgical Gown Proprietary Name: Med-Guard Surgical Gown Classification Name: Gown, Surgical
- This surgical gown is similar in design and composition to the Kimberly Clark gown identified in a (3) pre-market notification #K781682.
- The Kappler Med-Guard surgical gown is constructed from a tri-layer composite material which is a (4) 100% polypropylene. The specific arrangement is spunbonded polypropylene/meltblown polypropylene film/spunbonded polypropylene. The fabric is treated with an anti-static agent.
- The surgical gown is intended to protect the wearer from blood and other body fluids encountered a (5) during surgery.
- a (6) The following table provides a comparison of the technological characteristics of the Kappler Med-Guard surgical gown and the Kimberly-Clark surgical gown. Description of the test methods are provided in section b.1. The K-C results were obtained from their own published literature.
| CHARACTERISTIC | MED-GUARD | K-C |
|----------------------------------|--------------------|--------------------|
| Material Composition | 100% Polypropylene | 100% Polypropylene |
| Configuration | Tri-laminate | Tri-Laminate |
| Barrier Layer | Meltblown | Meltblown |
| Composite Weight | 1.8 oz./yd2 | 1.5 oz./yd2 |
| Hydrostatic Head | 44.0 cm | 20.7 inches |
| Bacterial Filtration | 78% | 81.3% |
| Moisture Vapor Transmission Rate | 1789 g/24 hm2 | 1794 grs/sqm/24 hr |
| Flammability | Class 1 | Class 1' |
| Sterilization | 100% ETO | 100% ETO |
| Anti-static treatment | Yes | Yes |
{1}------------------------------------------------
- The non-clinical testing was performed to describe the physical, barrier and comfort b (1) characteristics of the gown fabric. The individual test data sheets identify the samples as "Blue Hawk", which was a research and development name for the fabric in the Med-Guard gown.
Hydrostatic Pressure Resistance (ASTM D 751 Procedure B) - Provides a measure of the gown material resistance to a column of water. The results are expressed in the highest column resisted before failure occurs. See Enclosure A.
Bacterial Filtration Efficiency (SOP/ARO/007F.1/MIL-M-36954C) - Provides a measure of material resistance to bacteria laden aerosol with a mean particle size of approximately 3.0 microns. Results are expressed as a percentage of filtration. The test was performed on sterile material. See Enclosure B.
Moisture Vapor Transmission Rate (ASTM E 96 Method B) - Provides a measure of the gown material to pass water vapor and results are expressed in weight per unit area per unit time. Indicates a level of comfort for the wearer through ability to allow body perspiration to escape. See Enclosure C.
Standard Classification for Flammability (NFPA 702) - Provides a measure of the rate of burning of the gown material when ignited. Med-Guard shows the Class I flammability, which is defined as "relatively slow burning". See Enclosure D.
Ball Bursting Strength (ASTM D 751, Sec. 18.2) - Provides a measure of the physical strength of the gown material. Testing was performed on both sterile and non-sterile material to ensure sterilization would not adversely impact seam strength. See Enclosure E.
Breaking Strength (ASTM D 751, Sec. 11, Procedure A-Grab) - Provides a measure of the physical strength of the gown material. Testing was performed on both sterile and non-sterile material to ensure sterilization would not adversely impact physical strength. See Enclosure E.
Tear Strength (ASTM D 5733, Trapezoid Procedure) - Provides a measure of the physical strength of the gown material. See Enclosure E.
Colorfastness Evaluation of Non-wovens - Study consisted of performing water and saline extracts on the product after exposure to a normal steam cycle. See Enclosure E.
The product is 100% ETO sterilized. See Enclosure F.
- b (2) The clinical testing was performed to ensure the addition of the anti-static treatments presented no concerns of safety and effectiveness. The clinical protocol was established by North American Science Associates, Inc. (NAmSA). The protocol provided for the following testing:
Acute Systemic Toxicity - Hemolysis Test provides data to support no evidence of toxic effects from exposure to the treatment. See Enclosure G.
Cytotoxicity - MEM Emultion is a measure of the cytotoxicity of extractable substances exposed to cellular monolayers. See Enclosure H.
Delayed Contact Sensitization Study - Provides data to show no evidence of irritation from exposure to the treatment. See Enclosure I.
Based on the results of the testing, NAmSA concluded that no concerns of safety or effectiveness resulted from the addition of the anti-static treatment.
{2}------------------------------------------------
- The results of the non-clinical and clinical tests show the Kappler Med-Guard gown to be safe and b (3) effective. The results also show the gown to be equivalent to the predicate device.
-
.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 2000
Mr. Philip C. Mann Technical and Customer Support Manager Kappler Protective Apparel & Fabrics P.O. Box 218 35976 Guntersville, Alabama
Re : K992445 Trade Name: Med-Guard Surgical Gown Requlatory Class: II Product Code: FYA Dated: January 24, 2000 January 28, 2000 Received:
Dear Mr. Mann:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
{4}------------------------------------------------
Page 2 - Mr. Mann
the Federal Register. Please note: this response to your ene reactar notification submission does not affect any premarket notificacion baxilder sections 531 through 542 of obligation you might have the Electronic Product Radiation Che Act for devices ander one ederal laws or regulations.
This letter will allow you to begin marketing your device as first recei will as on the premarket notification. The FDA described in your sia ... puivalence of your device to a legally rinding of substancial equired in a classification for your markeed predicals and the your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in reguladiagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on Compriance at (501) 333 tising of your device, please contact che promocion and liver at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Informacion on Jourision of Small Manufacturers Assistance obeathed from eno number (800) 638-2041 or (301) 443-6597 or at at its corr rrec namber (6:1/www.fdaygov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Page **_ of _**
| Labels | Values |
|---------------------------|--------------------------|
| 510(k) Number (if known): | K992445 |
| Device Name: | MED-GUARD, Surgical Gown |
Indications For Use:
The gown is intended to protect the pa wearer from blood and other body fivids encountered during surgery
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter Use √
(Optional Format 1-2-96)
(Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices 510(k) Number _
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.
