(197 days)
K 100603
Not Found
No
The document describes a standard medical examination glove and makes no mention of AI or ML technology.
No
The device, a patient examination glove, is intended to prevent contamination between the patient and examiner, not to treat a disease or condition.
No
The device is a patient examination glove, which is used for protective barrier purposes and does not provide any diagnostic information or perform any diagnostic function.
No
The device is a physical glove, not software. The description clearly states it is a "powder-free patient examination glove" and "White Nitrile Medical Examination gloves".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "powder-free patient examination glove" worn on the hand or finger to prevent contamination. This is a barrier device for physical protection.
- Device Description: The description reinforces that it's a "Medical Examination glove" and references the relevant FDA regulation (21CFR 880.6250) which covers patient examination gloves, not IVDs.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biological markers
IVDs are used to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. This glove does not perform any such function.
N/A
Intended Use / Indications for Use
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is for over-the-counter use.
Product codes
LZA
Device Description
White Nitrile Medical Examination gloves powder free, non sterile, as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard Specification for Nitrile Examination Gloves. They are made from nitrile latex compound, white colour, powder free and non sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand or finger (of the examiner)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes) / Over-the-counter use
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)
K 100603
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Appendix 2
510(k) Summary Nitrile Examination Gloves Powder Free, White colour
1.0 Submitter:
K11292.8
Company Name: Riverstone Resources Sdn. Bhd.
Company Address: Lot 55& 56, No. 13&15 Jalan Jasmin 2 Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung Selangor, Malaysia.
Contact Person: Ms Chong Chu Mee
Telephone No: +603-60283033
Fax No: + 603-60283022
2.0 Preparation Date: 5th Jan 2012
3.0 Name of the Device
Trade Name/ Proprietary Name: RS WHITE Nitrile Medical Examination Gloves (Powder Free)
Device Name: Nitrile Patient Examination gloves
Device Classification Name: Patient Examination gloves (21 CFR 880.6250)
Device Class: Class I
Product Code : Nitrile - LZA
4.0 Identification of The Legally Marketed Device:
Class I patient Examination gloves, Powder Free, LZA which meets all the
requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250.
It is equivalent to K 100603, RS Safe Blue Nitrile Medical Examination Gloves
Powder Free (Non-Sterile) except for colour.
1
5.0 Description of Device
White Nitrile Medical Examination gloves powder free, non sterile, as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard Specification for Nitrile Examination Gloves. They are made from nitrile latex compound, white colour, powder free and non sterile.
6.0 Intended use of the Device
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It is for over-the-counter use.
7.0 Summary of the Technological Characteristics of the Devices compared to the Predicate Device for substantial equivalent discussion
There is no different technology characteristics compared to the predicate device except colour. Gloves are made from nitrile latex compound, White colour, powder free and non sterile. It is equivalent to K 100603, RS Safe Blue Nitrile Medical Examination Gloves Powder Free (Non-Sterile) except for colour.
2
| Characteristics | RS WHITE Nitrile
Medical Examination
Gloves (Powder Free) | RS Safe Blue Nitrile
Medical Examination
Gloves Powder Free
(Non-Sterile) K 100603 |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LZA | LZA |
| Intended use | A powder free patient
examination glove is a
disposable device
intended for medical
purposes that is worn
on the examiner's hand
or finger to prevent
contamination between
patient and examiner.
The device is for over-
the-counter use. | A powder free patient
examination glove is a
disposable device
intended for medical
purposes that is worn
on the examiner's hand
or finger to prevent
contamination between
patient and examiner.
The device is for over-
the-counter use. |
| Material use | Nitrile latex compound | Nitrile latex compound |
| Colour | White | Blue |
| Sterility | Non sterile | Non sterile |
| Dimensions | Meets ASTM D6319-10 | Meets ASTM D6319-00a |
| Physical properties | Meets ASTM D6319-10 | Meets ASTM D6319-00a |
| Freedom from pinholes | Meets ASTM D6319-10 | Meets ASTM D6319-00a |
| Powder-Free | Meets ASTM D6319-10 | Meets ASTM D6319-00a |
| Biocompatability test -
Primary Skin Irritation
Test | Passes | Passes |
| Dermal Sensitization | Passes | Passes |
| Assay | | |
| Characteristics | Standards | Device Performance |
| | | RS WHITE Nitrile Medical |
| | | Examination Gloves |
| | | Powder Free (Non-Sterile) |
| Dimension | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 | Meets |
| Freedom from pinholes | ASTM D 6319-10 | Meets |
| Powder-Free | ASTM D 6319-10 | Meets |
| Biocompatability | Primary Skin Irritation Test
Consumer Product Safety
Commission, Title 16,
Chapter II, Part 1500
Dermal Sensitization
Assay
- ISO 10993-10:2010(E) | Passes |
3
RS WHITE Nitrile Medical Examination Gloves Powder Free possesses the following technological characteristics compared to ASTM or Equivalent standards:
8.0 Conclusion
It can be concluded that White Nitrile Medical Examination Gloves (Powder Free) will perform according to the glove performance standards ASTM D 6319-10, biocompatibility requirement and FDA requirements and the labeling claims for the product.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Chong Chu Mee Technical Manager River Stone Resources Sdn. Bhd. Lot 55 & 56, NO. 13 & 15, Jalan Jasmin 2 Kawasan Perindustrian Bukit Beruntung, 48300 Bukit Beruntung Selangor, Malaysia
· Re: K112928
Trade/Device Name: RS WHITE Nitrile Medical Examination Gloves (Powder Free)
Regulation Number: 21 CFR 880.6250
Regulation Name: Patient Examination Glove
Regulatory Class: I
Product Code: LZA Dated: March 30, 2012 Received: April 4, 2012
Dear Ms. Chu Mee:
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.
APR 1 7 2012
5
Page 2 - Ms. Chu Mee
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
G. Anthony D. Watson, B.S., M.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
6
Appendix 1
INDICATION FOR USE
Riverstone Resources Sdn. Bhd.
510(K) Number: K112928
Device Name:
Applicant:
RS WHITE Nitrile Medical Examination Gloves
(Powder Free)
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dokie faugulis
(Division Sign-Off) (Division-Sign-On)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112928
Section 1A-1