(87 days)
A BPG powder-free latex surgical glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Powder-Free, Latex Surgical Glove
This document is a 510(k) premarket notification letter from the FDA to Best Putra Gloves SDN. BHD. regarding their Powder-Free Latex Surgical Glove. It confirms that the device is substantially equivalent to legally marketed predicate devices.
Crucially, this document is an FDA clearance letter for a medical device (a surgical glove), not a study report for an AI/ML medical device.
Therefore, none of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth is present in this document because it is not applicable to a traditional medical device 510(k) clearance in the way you've framed your questions for an AI/ML medical device.
To directly answer your numbered points based only on the provided text, and highlighting its irrelevance to your specific questions:
- A table of acceptance criteria and the reported device performance: This document does not contain a table of acceptance criteria or reported device performance in the context of an AI/ML medical device. For a surgical glove, performance criteria would typically involve barrier integrity (e.g., AQL for pinholes), physical properties (tensile strength, elongation), and biocompatibility, which are not detailed here. The letter only states that the device is "substantially equivalent."
- Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable and not mentioned. This document does not describe a test set or data provenance for an AI/ML algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable and not mentioned. The concept of "ground truth" established by experts for a test set is not relevant to a surgical glove's substantial equivalence determination.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable and not mentioned. Adjudication methods are used in studies involving human interpretation or labeling, which is not the case for a surgical glove.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable and not mentioned. This type of study is specific to AI-assisted diagnostic tools, not surgical gloves.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable and not mentioned. There is no algorithm involved with a surgical glove.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a physical device like a surgical glove relates to its physical and material properties meeting regulatory standards and predicate device characteristics, not to a diagnostic outcome.
- The sample size for the training set: Not applicable and not mentioned. There is no training set for a physical surgical glove.
- How the ground truth for the training set was established: Not applicable and not mentioned. There is no training set for a physical surgical glove.
In summary, the provided document is a regulatory clearance for a physical medical device (surgical glove) and does not contain the information requested, which is tailored for an AI/ML medical device study.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Dr. Effendi Tenang Managing Director Lot 1357 & 1358 Jin Kg. Best Putra Gloves SDN. BHD. Mohd Taib, Kawasan Perindustrian Sg. Choh 48000 Rawang, Selangor Darul Ehsan, Malaysia
JUL 1 6 2010
Re: K101102
Trade/Device Name: Powder-Free Latex Surgical Glove Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: April 5, 2010 Received: April 20, 2010
Dear Dr. Tenang:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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Page 2- Dr. Tenang
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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BEST PUTRA GLOVES SDN.BHD. (580515-T)
Lot 1357 & 1358, Jin Kg. Mond Taib, Kawasan Perindustrian Sg. Choh 48000 Rawang, Selangor Darul Ehsan, Malaysia. Tel: +03-6092 1042, +03-6092 1142 Fax: +03-6091 2820 E-mail : bpg@streamyx.com Website : www.bogloves.com
Image /page/2/Picture/3 description: The image contains two logos side by side. The first logo has the text "nga. ISO 9001 Registered" and the second logo has a crown and checkmark with the text "UKAS MANAGEMENT SYSTEMS 015". The second logo has the text "nga. ISO 14001 Registered" and the second logo has a crown and checkmark with the text "UKAS MANAGEMENT SYSTEMS 015".
Date: July 12, 2010
INDICATION FOR USE
Applicant: Best Putra Gloves Sdn Bhd
510K number:
Device Name: Powder-Free, Latex Surgical Glove
IIndication For Use: A BPG powder-free latex surgical glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination."
Sincerely,
Or
Richard Terlep
US Representative
Prescription use:
(per 21 CFR 801.109)
Over the counter use XXX
CONCURANT OF CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: k 101102
§ 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).