(9 days)
Not Found
Not Found
No
The device description and performance studies focus on the material properties and barrier protection of surgical gowns, with no mention of AI or ML technology.
No.
The device is a surgical gown, which is intended for protection from transfer of microorganisms and body fluids, not for treating a disease or condition.
No
The device is a surgical gown intended to protect patients and personnel from microorganism transfer, not to diagnose medical conditions.
No
The device description clearly states it is a surgical gown made of fabric and film, indicating it is a physical, hardware-based medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gowns are for protecting operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a barrier function, not a diagnostic function.
- Device Description: The description details the materials and construction of the gown, which are physical barriers. There is no mention of reagents, assays, or any components used to test samples from the human body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
This device is a Class II medical device (based on the information provided and the typical classification of surgical gowns) intended for infection control and barrier protection in a surgical setting.
N/A
Intended Use / Indications for Use
Surgical apparel are devices intended to be worn by operating room personnel during surgical procedures to protect both the surqical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
The Convertors®Breathable Surgical Gowns are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms. body fluids and particulate material.
Product codes
79 FYA
Device Description
The Breathable Surgical Gown consists of an outer and inner layer of spunmelt polyolefin nonwoven fabric with a middle layer of breathable monolithic film throughout the entire gown. The Breathable Sleeve Surgical Gown consists of sleeves containing a an outer and inner layer of spunmelt polyolefin nonwoven fabric with a middle layer of breathable monolithic film with a gown body comprised of spunmelt nonwoven (SMS) with a polyolefin-based film reinforcement.
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
operating room personnel during surgical procedures
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
All materials used in the fabrication of this Convertors®Breathable Gowns were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 " Biological Evaluation of Medical Devices''. The biocompatibility tests performed were cytotoxicity, sensitization, and irritation/ intracutaneous reactivity. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use.
Key Metrics
Not Found
Predicate Device(s)
Convertors® Breathable Surgical Gowns.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
OCT 02 2002
Allegiance
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461
KO23167
SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Breathable Surgical Gowns and Breathable Sleeve Surgical Gowns
| Manufacturer: | Allegiance Healthcare Corporation
One Butterfield Trail
El Paso, Texas 79906 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Sharon Nichols
1500 Waukegan Road MPWM
McGaw Park, IL 60085 |
| Telephone: | (847) 785-3311 |
| Date Summary Prepared: | September, 2002 |
| Common Name: | Convertors®Breathable Surgical Gowns
and Breathable Sleeve Surgical Gowns |
| Classification: | Class II per 21CFR § 878.4040 |
| Predicate Device: | Convertors® Breathable Surgical Gowns. |
| Description: | The Breathable Surgical Gown consists of an
outer and inner layer of spunmelt polyolefin
nonwoven fabric with a middle layer of
breathable monolithic film throughout the entire
gown. The Breathable Sleeve Surgical Gown
consists of sleeves containing a an outer and
inner layer of spunmelt polyolefin nonwoven
fabric with a middle layer of breathable
monolithic film with a gown body comprised of
spunmelt nonwoven (SMS) with a polyolefin-
based film reinforcement. |
1
Allegiance
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847 473 1500 FAX: 847.785.2461
SMDA REQUIREMENTS (continued)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Breathable Surgical Gowns
Surgical apparel are devices intended to be worn Intended Use: by operating room personnel during surgical procedures to protect both the surqical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
- Substantial The Convertors® gowns are substantially Equivalence: equivalent to the Convertors® Breathable gowns in that:
- the intended use is the same
- the performance attributes are similar
- Summary of testing: All materials used in the fabrication of this Convertors®Breathable Gowns were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 " Biological Evaluation of Medical Devices''. The biocompatibility tests performed were cytotoxicity, sensitization, and irritation/ intracutaneous reactivity. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 02 2002
Ms. Sharon Nichols Regulatory Affairs Manager Allegiance Healthcare Corporation 1500 Waukegan Road, Building WM McGaw Park, Illinois 60085-6787
Re: K023167
Trade/Device Name: Convertors® Breathable Surgical Gowns Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: 79 FYA Dated: September 20, 2002 Received: September 23, 2002
Dear Ms. Nichols:
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.
3
Page 2 - Ms. Nichols
Please be advised that FDA's issuance of a substantial equivalence determination docs 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Allegiance
Allegiance Healthcare 500 Waukenan Roa
Page 1 of 1
510(k) Number (if known):
KO23167 Накнөни
Device Name:
Indications For Use:
Convertors®Breathable Surgical Gowns
The Convertors®Breathable Surgical Gowns are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms. body fluids and particulate material.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per 21 CFR 801.109) or
Over-The Counter Use
Olia Sizin
General Hospital, ntrol Dental
510(k) Number: K023167