(64 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.
No.
The device is a surgical gown intended to protect personnel and patients from the transfer of microorganisms, body fluids, and particulate material, not to treat a disease, injury, or medical condition.
No
The device is a surgical gown intended to protect patients and personnel from transfer of microorganisms, body fluids, and particulate material during surgical procedures. It does not diagnose any condition or disease.
No
The device description clearly states the gowns are comprised of physical materials (spunlaced nonwoven fabric, polyolefin film) and are intended to be worn, indicating a physical hardware 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 surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a barrier function, not a diagnostic one.
- Device Description: The description details the materials and construction of a surgical gown, which is a physical barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on biocompatibility and material testing, not diagnostic accuracy.
IVD devices are used to examine specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This surgical gown does not perform any such function.
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 surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
The Convertors® 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 (comma separated list FDA assigned to the subject device)
FYA
Device Description
The gowns are comprised of a single base layer of degradable spunlaced nonwoven fabric in gown configurations of unreinforced, fabric reinforced and poly-reinforced. The fabric reinforced gown contains an additional layer of spunlaced nonwoven fabric in the chest and sleeves area. The poly-reinforced gown contains an additional layer of polyolefin film in the chest and sleeves of the gown.
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® Surgical 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 primary skin irritation. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use.
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.
Isolyser Industries Enviroguard Surgeons Gowns
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
FEB 1 8 2000
Image /page/0/Picture/1 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a stylized graphic that resembles a cluster of dots arranged in a cross-like shape. The word "Allegiance" is the primary focus of the image, and the graphic serves as a visual element associated with the text.
K9942yy
Allegiance Healthcare Corporation 1500 •• Ξ – egan Road McGa.v. Park. Illinois 60085-6787 847.473.1500
FAX: 847.785.2461
SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Surgical Gowns
| Manufacturer: | Allegiance Healthcare Corporation
One Butterfield Trail
El Paso, Texas 79906 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Sharon Robbins
1500 Waukegan Road MPWM
McGaw Park, IL 60085 |
| Telephone: | (847) 785-3311 |
| Date Summary Prepared: | September, 1999 |
| Common Name: | Convertors® Surgical Gowns |
| Classification: | Class II per 21CFR § 878.4040 |
| Predicate Device: | Isolyser Industries Enviroguard Surgeons Gowns |
| Description: | The gowns are comprised of a single base layer
of degradable spunlaced nonwoven fabric in
gown configurations of unreinforced, fabric
reinforced and poly-reinforced. The fabric
reinforced gown contains an additional layer of
spunlaced nonwoven fabric in the chest and
sleeves area. The poly-reinforced gown contains
an additional layer of polyolefin film in the chest
and sleeves of the gown. |
1
Image /page/1/Picture/0 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a graphic of a cross made up of small dots. The word is in black and the background is white.
Allegian se Healthcare Corporation 1500 Wajyegan Road McGaw -ark. Illinois 60085-6787 847.473 ・500
FAX: 8ニー 785.2461
SMDA REQUIREMENTS (continued)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Surgical Gowns
| Intended Use: | 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. |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | The Convertors® Surgical gowns are
substantially equivalent to the Isolyser
Enviroguard 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® Surgical 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 primary skin irritation.
These materials also were tested in accordance with
industry recognized test methods and were found to
be acceptable for the intended use. |
ー | 3,00000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 eagle with its wings spread, and its head turned to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
AUG 18 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sharon Robbins Regulatory Affairs Manager Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787
Re: K994244
Trade/Device Name: Convertors® Surgical Gowns Regulation Number: 878.4040 Regulation Name: Surgical apparel Regulatory Class: II Product Code: FYA Dated: December 14, 1999 Received: December 16, 1999
Dear Ms. Robbins:
This letter corrects our substantially equivalent letter of February 18, 2000.
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 (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 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. Robbins
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. 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 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97), You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Chiu S. Lin, Ph.D.
Chiu S. Lin, Ph. B Division 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 Corporation 1500 Vi Engegan Road McGar. Fark. Illinois 60085-6787 847.2-3 -500 AX 5-- 785.2461
Page 1 of 1
510(k) Number (if known):
Unknown K99A244
Device Name:
Convertors® Surgical Gowns, Sterile
Indications For Use:
The Convertors® 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) Over-The Counter Use Prescription Use ਾ (Per 21 CFR 801.109) (Division Sign-Off) Division of Dental, Infection C and General Hospital Device 510(k) Number