(202 days)
Not Found
No
The device description and performance studies focus on material properties and barrier standards, with no mention of AI/ML or data processing.
No.
The device is a surgical gown, which is a protective barrier worn by operating room personnel to prevent the transfer of microorganisms and fluids, not to directly treat a medical condition or ailment.
No
The description indicates the device is a surgical gown, used to protect personnel and patients from microorganisms and fluids. It does not mention any diagnostic function such as detecting, monitoring, or analyzing health conditions or diseases.
No
The device is a physical surgical gown made of non-woven fabric, not software. The description focuses on material properties, sterilization, and physical standards.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the surgical gowns are worn by operating room personnel to protect both the patient and the personnel 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 focuses on the material (non-woven fabric) and the fact that it's sterile and single-use. There is no mention of any components or processes related to analyzing samples from the human body.
- Lack of Diagnostic Elements: The entire description and the provided information lack any mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
- Performance Studies: The performance studies mentioned relate to barrier properties, flammability, and biological standards, which are relevant to protective apparel, not diagnostic devices.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. Surgical gowns, while important for infection control in a medical setting, do not perform this function.
N/A
Intended Use / Indications for Use
JOYKEY Surgical Gowns (Sterile) are single use article of surgical apparel 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.
Product codes
FYA
Device Description
JOYKEY Surgical Gowns (Sterile) are non-reinforced surgical Gowns manufactured from non-woven fabric. The surgical Gown is supplied sterile and for single use only.
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
Bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. The device conforms to ASTM F1670-03 Barrier properties against blood and body fluids & ASTM D1424 , ASTM D5034 & NFPA Flammability standards. The device also conforms to Biological standards of ISO 10993 series, Gamma Sterilization standard of ISO 11137.
Key Metrics
Not Found
Predicate Device(s)
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
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
MAR 1 4 2007
- JOYKEY INDUSTRYIAL LTD. 1 . Submitter's Name: Unit 7-8,23rd Floor, No. 1, Hung To Road, Kwun Tong, Address: KL . Hong Kong 852-2612-0951 Phone: Fax: 852-2615-9138 Ms. Ting-Yu Chang (President) Contact:
-
- Device Name Trade Name: JOYKEY Surgical Gowns(Sterile) Common Name: Sterile Surgical Gowns GOWN , SURGICAL Classification name:
- Classification: Class II 3.
- Predicate Device: 4.
- Device Description: 5.
JOYKEY Surgical Gowns (Sterile) are non-reinforced surgical Gowns manufactured from non-woven fabric. The surgical Gown is supplied sterile and for single use only.
Master & Frank Surgical Gowns (Sterile) (K012186)
marketed by Master & Frank Enterprise Co., Ltd.
- Intended Use: ్. JOYKEY Surgical Gowns (Sterile) are single use article of surgical apparel 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.
Section 4 - 510(k) Summary
1
- "Performance Summary: In terms of Physical specification, The dev to ASTM F1670-03 Barrier properties against blood and body fluids & ASTM D1424 , ASTM D5034 & NFPA Flammability standards --- etc. The device also conforms to Biological standards of ISO 10993 series, Gamma Sterilization standard of ISO 11137.
Conclusions: 8.
The JOYKEY Surgical Gowns (Sterile) have identical intended use and technological characteristics as the Master & Frank Surgical Gowns (Sterile) (K012186). Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the JOYKEY Surgical Gowns (Sterile) are substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of three human profiles facing to the right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that creates a sense of depth and unity. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2007
Joykey Industryial, Limited C/O Ms. Jennifer Reich 2904 North Boldt Drive Flagstaff, Arizona 86001
Re: K062479
Trade/Device Name: JOYKEY Surgical Gowns (Sterile) Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: February 15, 2007 Received: February 20, 2007
Dear Ms. Reich:
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
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
Page 2 -Ms. Reich
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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 (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), 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
CaeG
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _K 06 2479
Device Name: JOYKEY Surgical Gowns (Sterile) JOYKEY INDUSTRYIAL LTD.
Indications For Use:
JOYKEY Surgical Gowns (Sterile) are single use article of surgical apparel 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula A. Murphy, MD
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