(87 days)
Not Found
Not Found
No
The device description and intended use clearly indicate a standard surgical glove, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a surgical glove, which is used for protection, not for treating or curing a disease or condition.
No
The device is a surgical glove, which is used for protection, not for diagnosing medical conditions.
No
The device description clearly states it is a "Powder-Free, Latex Surgical Glove," which is a physical hardware device. There is no mention of software as the primary component or function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Description and Intended Use: The description clearly states that this is a surgical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. This is a physical barrier device used during a medical procedure, not a test performed on a sample outside the body.
The information provided about the device's intended use and description directly contradicts the definition of an IVD.
N/A
Intended Use / Indications 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.
Product codes
KGO
Device Description
Powder-Free, Latex Surgical Glove
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
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.
1
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
2
Image /page/2/Picture/0 description: The image shows the letters B, P, and G in a bold, outlined font. The letters are filled with a textured pattern, giving them a slightly distressed or vintage appearance. The background is plain, which makes the letters stand out.
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