(24 days)
Convertors®SMS Polyolefin Standard, Fabric and Poly-reinforced Gowns
Not Found
No
The 510(k) summary describes surgical gowns made of polyolefin fabric and does not mention any software, algorithms, or AI/ML capabilities.
No
A therapeutic device is one that treats or prevents a disease or condition. This device, a surgical gown, is intended to protect operating room personnel and patients from contamination, not to provide therapy.
No
The device, Convertors®SMS Polyolefin Gowns, is described as protective apparel for operating room personnel during surgical procedures to prevent the transfer of microorganisms, body fluids, and particulate material. Its function is to provide a physical barrier, not to diagnose medical conditions or diseases.
No
The device description clearly states it is comprised of fabric and polyolefin film, indicating it is a physical garment and not a software-only device.
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 operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a protective barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description details the materials and construction of the gowns, which are physical barriers. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
Therefore, the Convertors®SMS Polyolefin Gowns are classified as a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Convertors®SMS Polyolefin 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
FYA
Device Description
The standard, fabric- and poly-reinforced gowns are comprised of a single layer of SMS Polyolefin fabric. The fabric-reinforced gowns have an additional layer of SMS Polyolefin fabric in the sleeve and body areas; the poly-reinforced gowns have an additional layer of polyolefin film in the sleeve and body areas.
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 / operating room
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)
All materials used in the fabrication of this Convertors® SMS Polyolefin gown were evaluated through biological qualification safety tests as outlined in in ISO 10993 Part-1 " Biological Evaluation of Medical Devices". The biocompatibility tests performed were cytotoxicity, sensitization, and irritation/ intracutaneous reactivity. These materials have met the requirements of the guidance and were found to be acceptable for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Convertors®SMS Polyolefin Standard, Fabric and Poly-reinforced 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
MAR 1 8 2002
Allegiance
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461
SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors®SMS Polyolefin Gowns
Manufacturer:
Allegiance Healthcare Corporation One Butterfield Trail El Paso, Texas 79906
Allegiance Healthcare Corporation 1500 Waukegan Road MPWM-1E
Requlatory Affairs Contact:
Telephone:
(847) 785-3311
Sharon Robbins
McGaw Park, IL 60085
Date Summary Prepared:
Common Name:
Classification:
Predicate Device:
Description:
February, 2002
Convertors®SMS Polyolefin Gowns
Class II per 21CFR § 878.4040
Convertors®SMS Polyolefin Standard, Fabric and Poly-reinforced Gowns
The standard, fabric- and poly-reinforced gowns are comprised of a single layer of SMS Polyolefin fabric. The fabric-reinforced gowns have an additional layer of SMS Polyolefin fabric in the sleeve and body areas; the poly-reinforced gowns have an additional layer of polyolefin film in the sleeve and body areas.
30
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®SMS Polyolefin Gowns
Intended Use:
Substantial Equivalence:
Surgical apparel 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.
The Convertors® SMS Polyolefin gown is substantially equivalent to the Convertors® SMS Polyolefin standard, fabric- and polyreinforced gowns in that:
- the intended use is the same
- the performance attributes are the same
All materials used in the fabrication of this Convertors® SMS Polyolefin gown were evaluated through biological qualification safety tests as outlined in in ISO 10993 Part-1 " Biological Evaluation of Medical Devices". The biocompatibility tests performed were cytotoxicity, sensitization, and irritation/ intracutaneous reactivity. These materials have met the requirements of the guidance and were found to be acceptable for the intended use.
Summary of testing:
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 is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized eagle or bird in flight, composed of three curved lines. The text is arranged around the perimeter of the circle, with the department's name clearly visible.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 8 2002
Ms. Sharon Robbins Regulatory Affairs Manager Allegiance Healthcare Corporation 1500 Waukegan Road, MPWM-1E McGraw Park, Illinois 60085
Re: K020593
Trade/Device Name: Convertors® SMS Polyolefin Gown Regulation Number: 878.4040 Regulation Name: Surgical Gowns Regulatory Class: II Product Code: FYA Dated: February 21, 2002 Received: February 22, 2002
Dear Ms. Robbins:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your and have determined the device is substantially equivalent (for the rections 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 the Fodelar F ood, Drag, and Connenay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents or a 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 If your device is clabelieve (such additional controls. Existing major regulations affecting (1 NET), it inch of our any of 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.
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.
3
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 roquicable as 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 110(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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
K. Wlatrust
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
Allegiance
a Cardinal Health company
rk. Illinois 60085-6
Page 1 of 1
510(k) Number (if known):
K020593 Waknown
Device Name:
Convertors®SMS Polyolefin Gown
Indications For Use:
The Convertors®SMS Polyolefin 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) Over-The Counter Use Prescription Use or (Per 21 CFR 801.109) 25