(211 days)
Not Found
No
The device is a surgical gown and the description focuses on material composition and physical properties, with no mention of AI or ML.
No.
The primary purpose of the device is to protect the wearer during surgery, not to treat a disease or condition.
No
The device is a surgical gown, intended to protect the wearer from blood and other body fluids during surgery. It does not perform any diagnostic function.
No
The device is a surgical gown, which is a physical product made of fabric, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "protect the wearer from blood and other body fluids encountered during surgery." This is a protective barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction and material of a surgical gown. This is consistent with a personal protective equipment (PPE) device, not an IVD.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting specific analytes or markers
- Providing diagnostic information about a patient's health status
- Reagents, assays, or analytical procedures
The information provided clearly describes a surgical gown designed for physical protection during surgery, which falls under the category of medical devices but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The gown is intended to protect the wearer from blood and other body fluids encountered during surgery.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
The Kappler Med-Guard surgical gown is constructed from a tri-layer composite material which is 100% polypropylene. The specific arrangement is spunbonded polypropylene/meltblown polypropylene film/spunbonded polypropylene.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed to describe the physical, barrier and comfort characteristics of the gown fabric. Tests performed include: Hydrostatic Pressure Resistance (ASTM D 751 Procedure B), Bacterial Filtration Efficiency (SOP/ARO/007F.1/MIL-M-36954C), Moisture Vapor Transmission Rate (ASTM E 96 Method B), Standard Classification for Flammability (NFPA 702), Ball Bursting Strength (ASTM D 751, Sec. 18.2), Breaking Strength (ASTM D 751, Sec. 11, Procedure A-Grab), Tear Strength (ASTM D 5733, Trapezoid Procedure), and Colorfastness Evaluation of Non-wovens.
Clinical testing was performed to ensure the addition of the anti-static treatments presented no concerns of safety and effectiveness. Tests performed include: Acute Systemic Toxicity - Hemolysis Test, Cytotoxicity - MEM Emulsion, and Delayed Contact Sensitization Study. Based on the results, NAmSA concluded that no concerns of safety or effectiveness resulted from the addition of the anti-static treatment. The results of non-clinical and clinical tests show the Kappler Med-Guard gown to be safe and effective and equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Hydrostatic Head: 44.0 cm
Bacterial Filtration: 78%
Moisture Vapor Transmission Rate: 1789 g/24 hm2
Flammability: Class 1
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4040 Surgical apparel.
(a)
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.(b)
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
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 _