(61 days)
Isolation for Far-East Barrier Gowns
Far-East Barrier Gowns are disposable and single use devices, for general medical purposes, that are worn on to intended protect the isolation patients, medical staffs and visitors from transfer of micro-organisms, body fluids and particulate material during the general medical procedures and patient room visits in hospitals. These devices are non-sterile, not intended to be used by O. R. personnel for surgical procedures.
Far-East Barrier Gowns are disposable and single use devices, for general medical purposes, that are worn on to intended protect the isolation patients, medical staffs and visitors from transfer of micro-organisms, body fluids and particulate material during the general medical procedures and patient room visits in hospitals. These devices are non-sterile, not intended to be used by O. R. personnel for surgical procedures.
This document is an FDA 510(k) clearance letter for "Far-East Isolation Gowns." It does not contain information about acceptance criteria or a study proving device performance in the context of an AI-powered medical device.
The letter explicitly states: "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 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)."
Substantial equivalence is based on comparing the new device to a predicate device, not on specific performance criteria demonstrated through a clinical study as would be expected for an AI device.
Therefore, I cannot provide the requested information. The document pertains to general medical gowns, not an AI device, and the clearance is based on substantial equivalence, not a performance study.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Far East Science & Technology Development Company C/O Mr. David X. Song U.S. Contact Person 11250 Dale Street #59 Garden Grove, California 92841
JUL - 8 1997
K971702 Re : Far-East Isolation Gowns Trade Name: Regulatory Class: II FYC Product Code: Dated: June 23, 1997 Received: June 26, 1997
Dear Mr. Song:
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 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 against 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਚੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Fractice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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
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through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). 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/dsmamain.html".
Sincerely yours,
K. Alakaki
A. Timo Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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中国，武汉430079.
武昌珞瑜路196号
TEL: (27) 740-2265
(27) 780-3585
FAX: (27) 740-2264
FAR - EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO. , LTD
STATEMENT DEVICE INDICATION FOR USE
Isolation for Far-East Barrier Gowns
Far-East Barrier Gowns are disposable and single use devices, for general medical purposes, that are worn on to intended protect the isolation patients, medical staffs and visitors from transfer of micro-organisms, body fluids and particulate material during the general medical procedures and patient room visits in hospitals. These devices are non-sterile, not intended to be used by O. R. personnel for surgical procedures.
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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR (Per 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96)
§ 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.