(72 days)
A Surgeon's glove is a device made of natural or synthetic rubber * intended to be worn by operating room personnel to protect a surgical wound from contamination.
SURGEON'S "POWDER-FREE"STERILE LATEX GLOVES
The given text is a 510(k) clearance letter from the FDA for "Latex Surgical Gloves Powder-Free". This document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance studies and acceptance criteria analysis typical for more complex medical devices or AI algorithms.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be found in this document. The letter confirms regulatory approval for marketing, not a scientific study report with performance metrics.
However, based on the provided text, I can infer the following:
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Acceptance Criteria and Reported Device Performance: Not explicitly stated. The acceptance for regulatory clearance is based on "substantial equivalence" to a predicate device. This implies the device meets the basic performance and safety standards of similar legally marketed devices. For surgical gloves, this would typically involve standards related to sterility, barrier integrity (e.g., freedom from pinholes), strength, and biocompatibility, but no specific numerical criteria or reported results are in this document.
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Sample Size Used for Test Set and Data Provenance: Not applicable. This document does not describe a clinical study with a test set of data.
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Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable. This document does not describe a process of establishing ground truth by experts.
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Adjudication Method for the Test Set: Not applicable.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not a study of human readers or AI assistance.
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Standalone Performance Study: Not applicable in the context of an algorithm. For a physical device like a glove, performance standards would have been met but are not detailed here.
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Type of Ground Truth Used: Not applicable.
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Sample Size for the Training Set: Not applicable.
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How Ground Truth for the Training Set Was Established: Not applicable.
Summary based on the document:
This document is a 510(k) clearance, a regulatory process to demonstrate that a device is as safe and effective as a legally marketed predicate device. It is not a report on a clinical or performance study with detailed acceptance criteria and results as typically understood for AI/ML devices or complex medical devices. The "acceptance criteria" here refer to regulatory requirements for substantial equivalence, which would have been supported by underlying testing data not included in this letter.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1999
Ms. Danielle Cottet Quality Controller Wear Safe Malaysia Lot 1, Leboh Hishamuddin Satu North Klang Straits Industrial Area 42000 Port Klang Selangor Darul Ehsan, West Malaysia
Re: K992679 Latex Surqical Gloves Powder-Free Trade Name: Chlorinated Regulatory Class: I Product Code: KGO Dated: July 30, 1999 Received: August 10, 1999
Dear Ms. Cottet:
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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
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Page 2 - Ms. Cottet
the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 leqally 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) 594-4692. 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Kj Alutrist
Timothy A. II atows 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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Image /page/2/Picture/0 description: The image shows the logo for Wear Safe Malaysia (WSM). The logo has the letters WSM in large bold font, with the words "WEAR SAFE MALAYSIA" underneath. To the right of the letters is a symbol that looks like a plus sign. The text below the logo says "(Formerly known as WUHRLIN SOPLAMED (M) SDN. BHD.)" and "SDN. BHD. (204396-X)".
ANNEX 1
Page 01 of 01
510 (k) Number (if known) : K992679
Device Name :
SURGEON'S "POWDER-FREE"STERILE LATEX GLOVES
Indications For Use :
A Surgeon's glove is a device made of natural or synthetic rubber * intended to be worn by operating room personnel to protect a surgical wound from contamination.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Presription Use __
OR
Over-The -Counter Use
(Per 21 CFR 801.109)
Qlin S. Lin
(Optional format 1-2-96)
(Division Sign-Off Division of Da ntal, Infe and General Hos 510(k) Number
§ 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).