(87 days)
A BPG powdered 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. This excludes the lubricating or dusting powder used in the glove.
Powdered, Latex Surgical Glove
This document is an FDA 510(k) clearance letter for a Powdered Latex Surgical Glove. It is a regulatory approval document and does not contain any information about a study or acceptance criteria related to a medical AI/ML device.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, ground truth, or MRMC comparative effectiveness studies because this document pertains to a physical medical device (surgical gloves), not an AI/ML system.
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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 Jln Kg. Best Putra Gloves SDN. BHD. Mohd Taib, Kawasan Perindustrian Sg. Choh 48000 Rawang, Selangor Darul Ehsan, Malaysia
JUL 1 6 2010
Re: K101103
Trade/Device Name: Powdered 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 (OS) 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/Resourcesfor You/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 SON.BHD. (5805151) Lot 1357 & 1358, Jin Kg. Mohd Taib, Kawasan Perindustrian Sg. Choh 48000 Rawang, Selangor Darul Ehsan, Malaysia,
Tel: +03-6092 1042, +03-6092 1.142 Fax: +03-6091, 2820 E-mail : bog@streamyx.com Website : www.bngloves.com
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Date: July 12, 2010
INDICATION FOR USE
Applicant: Best Putra Gloves Sdn Bhd
510K number:
Powdered, Latex Surgical Glove Device Name:
Indication For Use: A BPG powdered 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. This excludes the lubricating or dusting powder used in the glove,
Sincerely,
Or
Signature
Richard-Terlep US Representative
Prescription use: (per 21 CFR.801.109)
Over the counter use
CONCURANT OF CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K101103 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).