(26 days)
A powdered surgeon's glove is a disposable device made of synthetic-co-polymer that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
A powdered surgeon's glove is a disposable device made of synthetic-co-polymer that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
This document is a 510(k) premarket notification letter from the FDA regarding a surgical glove, not a study or report on an AI/ML medical device. Therefore, the requested information about acceptance criteria, study details, ground truth, experts, and sample sizes for an AI device cannot be extracted from the provided text.
The document states that the FDA has determined the ElastyLite® Synthetic Powdered Surgical Glove is "substantially equivalent" to legally marketed predicate devices. This determination is based on the device's characteristics and intended use being similar enough to existing devices that it does not require a new premarket approval application (PMA).
To answer your prompt, I would need a different type of document, specifically a clinical study report, a performance evaluation report, or a 510(k) summary for an AI/ML-based medical device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
JUN 1 0 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Shirantha Samarappuli Ouality Assurance Manager ECI Medical Technologies, Incorporated 2 Cook Road Bridgewater, Nova Scotia, CANADA B4V 3W7
Re: K021598
Trade/Device Name: ElastyLite® Synthetic Powdered Surgical Glove Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: May 14, 2002 Received: May 15, 2002
Dear Ms. Samarappuli:
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.
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Page 2 -- Ms. Shirantha Samarappuli
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 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,
Timothy A. Ulatowski
Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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ElastyLite® Synthetic Copolymer Powdered Surgical Glove ECI Medical Technologies Inc 2 Cook Road Bridgewater NS Canada B4V 3W7 1: 902 543 6665 Fax: 902 543 6644
CONFIDENTIAL
PROPRIETARY
Attachment 4 (in revisions/additional information - May 23, 2002)
Indications for Use Statement
K 02 15 98 510(k) Number: _
Device Name: ElastyLite® Synthetic Copolymer Powdered Surgical Glove
Indications for Use:
A powdered surgeon's glove is a disposable device made of synthetic-co-polymer that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use_
Chân Si Lin
(Division Sign-Off of Dental, Intec
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).