(212 days)
A powder-free patient examination gloves 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.
RS BLACK Black Medical Examination Nitrile gloves (powder free) 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, black colour and powder free.
The document describes the acceptance criteria and performance of "RS BLACK Black Nitrile Medical Examination Gloves (Powder Free)".
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Standard (Acceptance Criteria) | Device Performance (RS BLACK Black Nitrile Medical Examination Gloves Powder Free) |
|---|---|---|
| Product Code | LZA | LZA |
| Intended use | Disposable device for medical purposes, worn on examiner's hand/finger to prevent contamination between patient and examiner. For over-the-counter use. | Matches standard intended use. |
| Material use | Nitrile latex compound | Nitrile latex compound |
| Colour | N/A (Predicate is Blue) | Black |
| Dimensions | 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 |
| Biocompatibility (Primary Skin Irritation Test) | Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 (ISO 10993-10:2010(E)) | Passes |
| Biocompatibility (Dermal Sensitization) | Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 (ISO 10993-10:2010(E)) | Passes |
2. Sample size used for the test set and the data provenance:
The document doesn't explicitly state the sample sizes for the tests conducted to prove compliance with ASTM D 6319-10 or biocompatibility. The country of origin of the device manufacturer is Malaysia. The data appears to be prospective testing conducted for regulatory submission, as it describes the properties of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The tests refer to compliance with established standards (ASTM D 6319-10, ISO 10993-10:2010(E)), which typically involve standardized testing protocols and measurements rather than expert consensus on individual cases.
4. Adjudication method for the test set:
Not applicable. The tests are against objective standards (e.g., physical properties, pinhole incidence, biocompatibility).
5. 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. This device is a medical examination glove, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a medical examination glove, not an algorithm.
7. The type of ground truth used:
The ground truth used is based on established industry standards and regulatory requirements. For physical properties (dimensions, tensile strength, freedom from pinholes, powder residue), the ground truth is defined by the specifications outlined in ASTM D 6319-10. For biocompatibility (Primary Skin Irritation Test and Dermal Sensitization), the ground truth is defined by the pass/fail criteria within ISO 10993-10:2010(E) and Consumer Product Safety Commission regulations.
8. The sample size for the training set:
Not applicable. This device is a physical product, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this device.
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MAY - 2 2012
Appendix 2
510(k) Summarv Nitrile Examination Gloves Powder Free, Black colour
1.0 Submitter:
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 Name of the Device Trade Name/ Proprietary Name: RS BLACK Black 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
3.0 Identification of The Legally Marketed Device:
Class I patient Examination gloves, Powder Free, LZA and meets all the
requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250.
Predicate Device: RS Safe Blue Nitrile Medical Examination Gloves Powder Free (Non-Sterile) (K100603)
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Appendix 2
4.0 Description of Device
RS BLACK Black Medical Examination Nitrile gloves (powder free) 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, black colour and powder free.
5.0 Intended use of the Device
RS BLACK Black Nitrile Medical Examination Gloves (Powder Free) 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.
- 6.0 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, black colour and powder free. It is equivalent to K 100603, RS Safe Blue Nitrile Medical Examination Gloves Powder Free (Non-Sterile) except for colour.
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Appendix 2
| Characteristics | RS BLACK Black NitrileMedical ExaminationGloves Powder Free (Non-Sterile) | RS Safe Blue NitrileMedical ExaminationGloves Powder Free(Non-Sterile), K 100603 |
|---|---|---|
| Product Code | LZA | LZA |
| Intended use | RS BLACK BlackNitrile MedicalExamination GlovesPowder Free (Non-Sterile) is a disposabledevice intended formedical purposes that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner.The device is for over-the-counter use. | RS Safe Blue NitrileMedical ExaminationGloves Powder Free(Non-Sterile) is adisposable deviceintended for medicalpurposes that is wornon the examiner's handor finger to preventcontamination betweenpatient and examiner.The device is for over-the-counter use. |
| Material use | Nitrile latex compound | Nitrile latex compound |
| Colour | Black | Blue |
| Dimensions | Meets ASTM D6319-10 | Meets ASTM D6319-00a |
| Physical porperties | 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 IrritationTest | Passes | Passes |
| Dermal Sensitization | Passes | Passes |
| Assay | ||
| Characteristics | Standards | Device Performance |
| RS Safe Black Nitrile | ||
| Medical Examination | ||
| Gloves (Powder Free) | ||
| 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 | Passes |
| Consumer Product SafetyCommission, Title 16,Chapter II, Part 1500 | ||
| Dermal Sensitization | Passes | |
| Assay | ||
| - ISO 10993-10:2010(E) |
:
.
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K112924
Appendix 2
RS BLACK Black Nitrile Medical Examination Gloves (Powder Free) possesses the following technological characteristics compared to ASTM or Equivalent standards:
7.0 Conclusion
It can be concluded that RS BLACK Black Nitrile Medical Examination gloves (Powder Free) perform according to the glove performance standards ASTM D 6319-10, biocompatibility requirement and FDA requirements and the labeling claims for the product. It is perform as well as the legally marketed predicate devices in 3.0
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY - 2 2012
Ms. Chong Chu Mee Technical Manager Riverstone Resources Sdn. Bhd. Lot 56, NO. 15, Jalan Jasmin 2 Bukit Beruntung, Selangor MALAYSIA 48300
Re: K112924
Trade/Device Name: RS BLACK Black Nitrile Medical Examination Gloves (Powder Free) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: April 4, 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.
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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,
Anthony D. mAtre
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
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INDICATION FOR USE
Applicant:
Riverstone Resources Sdn. Bhd.
KII2924 510(K) Number:
Device Name:
RS BLACK Black Nitrile Medical Examination
Gloves (Powder Free)
A powder-free patient examination gloves 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 Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR
(Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (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)
Elizabeth B. Clamin- Will-
Division Sign-Off) Jivision of Anesthesiology, General Hospital nfection Control, Dental Devices
:10(k) Number: K112924
Section 1A-1
§ 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.