(84 days)
Not Found
Not Found
No
The 510(k) summary describes a surgical gown made of fabric and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is a surgical gown intended to protect healthcare workers from transfer of microorganisms, body fluids, and particulate matter, not to treat a disease or condition.
No
Explanation: The device is a surgical gown, which is a protective barrier for healthcare workers, not a device used to diagnose medical conditions or diseases. Its purpose is to prevent the transfer of microorganisms, body fluids, and particulate matter.
No
The device description clearly states it is a physical gown made of fabric, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gowns are for protecting healthcare workers from the transfer of microorganisms, body fluids, and particulate matter. This is a protective barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical properties of the fabric and its ability to resist penetration. This aligns with a protective garment, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the physical and biological safety of the gown itself (cytotoxicity, skin irritation, fluid/viral penetration, flammability), not on the accuracy or reliability of a diagnostic test.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The MicroCool gown is a single use item of surgical apparel intended to be worn by health care professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter. The MicroCool gown was designed to provide a barrier to fluids such as water, blood, sweat and isopropyl alcohol while allowing the wearer to remain comfortable.
The MicroCool Surgical Gown and the MicroCool Isolation Gown are single use items of surgical apparel intended to be worn by health are worker from the transfer of microorganisms, body fluids and particulate matter.
Product codes (comma separated list FDA assigned to the subject device)
FYC, FYA
Device Description
The MicroCool gown is manufactured from a breathable, repellent, non-woven, polypropylene fabric, The fabric is a three-layer lamination that resists tearing and penetration by liquids. This disposable gown is supplied sterile or non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals
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)
| Test | Result |
|---|---|
| Cytotoxicity | No evidence of component sensitizer (met USP XXIII requirements) |
| Skin Irritation | No evidence of dermal irritation |
| Sterilant residues | Levels of EO, EC and EG were each within the proposed FDA limits for medical devices that contact skin |
| Flammability | Meets Class I flammability requirements per 16 CFR Part 1610 |
| Fluid penetration | Resists visual penetration by blood and viral penetration fluids (met ASTM 1670-97 & ASTM F 903-96 requirements) |
| Viral penetration | Resists viral penetration (met ASTM F 1671-97a requirements) |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
3M Prevention Fabric Surgical Gown
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
JUL | 0 |998
i
Image /page/0/Picture/3 description: The image contains a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '981393'. The numbers are written in a simple, slightly slanted style, and the overall impression is that of a quickly jotted down note.
510(k) Summary of Safety and Effectiveness
| Manufacturer: | Kimberly-Clark Corporation
1400 Holcomb Bridge Road
Roswell, GA 30076 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs
Contact: | Larry R. Kludt
Manager Regulatory Affairs
1400 Holcomb Bridge Road
Roswell, GA 30076
(770) 587-8279 |
| Summary Date: | July 1, 1998 |
| Product Trade
Name: | MicroCool™ Surgical Gown (sterile)
MicroCool™ Isolation Gown (nonsterile) |
| Common Name: | Surgical gown, Isolation gown |
| Classification: | Surgical apparel |
| Predicate Device: | 3M Prevention Fabric Surgical Gown |
| Description: | The MicroCool gown is manufactured from a breathable,
repellent, non-woven, polypropylene fabric, The fabric is a three-
layer lamination that resists tearing and penetration by liquids.
This disposable gown is supplied sterile or non-sterile. |
| Intended Use: | The MicroCool gown is a single use item of surgical apparel
intended to be worn by health care professionals to help protect
both the patient and the healthcare worker from the transfer of
microorganisms, body fluids and particulate matter. The
MicroCool gown was designed to provide a barrier to fluids such
as water, blood, sweat and isopropyl alcohol while allowing the
wearer to remain comfortable. |
| Substantial
Equivalence: | The MicroCool gown is substantially equivalent to the 3M
Prevention Fabric Gown manufactured by 3M Health Care in that
they both provide the following characteristics: |
-
good tear resistance
fluid barrier 로 로
1
Summary of Testing;
.
l
·
| Test | Result |
|---|---|
| Cytotoxicity | No evidence of component |
| sensitizer (met USP XXIII | |
| requirements) | |
| Skin Irritation | No evidence of dermal |
| irritation | |
| Sterilant residues | Levels of EO, EC and EG were |
| each within the proposed FDA | |
| limits for medical devices that | |
| contact skin | |
| Flammability | Meets Class I flammability |
| requirements per 16 CFR Part | |
| 1610 | |
| Fluid penetration | Resists visual penetration by blood |
| and viral penetration fluids | |
| (met ASTM 1670-97 & ASTM F | |
| 903-96 requirements) | |
| Viral penetration | Resists viral penetration |
| (met ASTM F 1671-97a | |
| requirements) |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and head. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
10 1 0 1398
Kimberly-Clark Corporation C/O Mr. Larry R. Kludt Manager Requlatory Affaris 1400 Holcomb Bridge Road Roswell, Georgia 30076
Re : K981393 MicroCool™ Nonsterile Disposable Isolation Trade Name: Gown and MicroCool™ Sterile Disposable Surgical Gown Regulatory Class: II FYC and FYA Product Code: Dated: April 16, 1998 Received: April 17, 1998
Dear Mr. Kludt:
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 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). 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 aqainst 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 Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
3
Page 2 - Mr. Kludt
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 in a crassification for your
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the requires artition artition at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to a premarket notification" (21CFR 807.97) . 1 Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
. Enclosure_… ...
4
| 510(k) Number (if known): | K981393 |
|---|---|
| --------------------------- | --------- |
Sterile
Non Sterile
| Device Name: | Disposable MicroCool Surgical Gown, MicroCool Isolation Gown, DISPOSABLE |
|---|---|
| -------------- | -------------------------------------------------------------------------- |
Indications For Use:
The MicroCool Surgical Gown and the MicroCool Isolation Gown are single use items of surgical apparel intended to be worn by health are worker from the transfer of microorganisms, body fluids and particulate matter.
(PLEASE DO NOT WILLTE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurence of CDRH, Office of Device Evaluation (ODE)
Chus. Lin
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K981393
Prescription Use (Pct 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Formal 1-2-96)