(48 days)
Not Found
Not Found
No
The 510(k) summary describes a standard surgical glove and contains no mention of AI, ML, or related concepts.
No
The device is a surgeon's glove, intended to protect a surgical wound from contamination, not to provide therapy.
No
Explanation: The device is described as a "Surgeon's Glove" intended to protect a surgical wound from contamination, not to diagnose a condition or disease.
No
The device description clearly states it is a physical glove made of natural or synthetic rubber, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Intended Use: The intended use of the Royal Guard Latex, Powder-Free, Surgeon's Glove is to be worn by operating room personnel to protect a surgical wound from contamination. This is a barrier device used on the body (or on the hands of the user) during a medical procedure.
- Lack of Diagnostic Function: The description does not mention any function related to testing samples or providing diagnostic information.
Therefore, based on the provided information, the Royal Guard Latex, Powder-Free, Surgeon's Glove is a medical device, but it falls under a different category than In Vitro Diagnostics. It is a surgical glove, which is a Class I or Class II medical device depending on its specific characteristics and intended use.
N/A
Intended Use / Indications for Use
The Royal Guard Latex, Powder-Free, Surgeon's Glove - Sterile, is a device made of natural rubber or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination between patient and operating room personnel.
Product codes
KGO
Device Description
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized graphic of three wavy lines that resemble a human figure.
SEP 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Anan Jetsadawisut Managing Director Managing Diroctor
Shun Thai Rubber Gloves Industry Public Co., Ltd. 9, Moo 4, Kached Muang, Rayong 21110 THAILAND
Re: K052030
K052050
Trade/Device Name: Surgeon's Glove Powder Free Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: September 7, 2005 Received: September 9, 2005
Dear Mr. Jetsadawisut:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section - Forty premained in substantially equivalent (for the indications referenced above and have decembined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices Amendments for use stated in the encrosure for legally manced promotical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the charge with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require upproval of the general controls provisions of the Act. The Act. The You may, therefore, market the device, but in gents for annual registration, listing of
general controls provisions of the Act include requirements for answereding and general controls provisions of the Fret mercial requirement misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (See above) mo chairs are regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA may may be subject to such adultional controlls. Extrems and to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 Register be found in the Code of Federal Regarations, would be in the Federal Register.
1
Page 2 - Mr. Jetsadawisut
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a subsmither requirements of the Act
that FDA has made a determination that your device of an Fareseas. You must that FDA has made a determination and your areas by other Federal agencies. You must
or any Federal statutes and regulations administered by registration and listin or any Federal statules and regulations administed to: registration and listing (21 l
comply with all the Act's requirements, including, but not reasurements as set comply with all the Act S requirements, mendably on and ice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electronic CFR Part 807); labeling (21 CFR Part 800); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Patt 820); and if applicable, the electronic forth in the quality systems (Q5) regulation (Sections 531-542 of the Acction S product radiation control provisions (occions of the saces ))
This letter will allow you to begin marketing your device of your device to a legal This letter will allow you to begin makemig your aftire as walevice of your device to a legally
premarket notification. The FDA finding of substantial equipe and this permit premarket notification. The FDA inding of substantial equivalence 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), please
r the results of the may and 15 at the colors note the regulation entitled If you desire specific advice for your de not on S. Also, please note the regulation entitled, contact the Office of Complance at (246) 276 - 6178 (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may ob "Misbranding by reference to prehance notifieddender the Act from the Division of Small
other general information on your responsibilities under the Act from worker (800) 638 other general information on your responsion its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-fired status and Manufacturers, International and Consumer Association of and consisted on the manufactures html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT
APPLICANT:
Shun Thai Rubber Gloves Industry Public Company, Ltd.
510(k) NUMBER (if known): K052030_
DEVICE NAME: Royal Guard Latex, Powder-Free, Surgeon's Glove - Sterile
Indications For Use:
The Royal Guard Latex, Powder-Free, Surgeon's Glove - Sterile, is a device made of The Royal Quard Latex, Forver 1100, Salgers by operating room personnel to natural '01 synthette rubber intended to so m.
protect a surgical wound from contamination between patient and operating room personnel.
Prescription Use ... ... ................ Per 21 CFR 801.109
AND/OR
Over-The-Counter Use ... ... .............................. (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrentce of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Anesthesiology General Hospital, | ||
| Infection Control, Dental Devices | ||
| 510(k) Number | K052030 | |
| Revised 31 Aug 2005 | ||
atch "