(135 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.
Latex Examination gloves powder free as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LYY (21CFR 880.6250). It meets all the specifications in ASTM D 3578-05, Standard Specification for Latex Examination Gloves. They are made from natural latex compound and powder free.
This document describes the regulatory submission for the "RS Care Latex Examination Gloves Powder Free." It's important to note that this is a 510(k) summary for a medical device (gloves), not an AI/ML powered device. Therefore, many of the requested categories in your prompt, such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone algorithm performance," "sample size for the training set," and "adjudication method," are not applicable.
Here's the breakdown based on the provided text, focusing on the relevant acceptance criteria and study information for this type of device:
Acceptance Criteria and Device Performance Study for RS Care Latex Examination Gloves Powder Free
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standards | Acceptance Criteria (Met/Not Met) | Device Performance |
|---|---|---|---|
| Dimension | ASTM D 3578-05 | Met | Meets |
| Physical Properties | ASTM D 3578-05 | Met | Meets |
| Freedom from pinholes | ASTM D 3578-05 | Met | Meets |
| Powder-Free | ASTM D 3578-05 | Met | Meets |
| Protein Content | ASTM D 3578-05 | Met | Meets |
| Biocompatibility | Primary Skin Irritation Test (Consumer Product Safety Commission, Title 16, Chapter II, Part 1500) | Met | Passes |
| Dermal Sensitization Assay (ASTM-F 720-81, Reapproved 2007) | Met | Passes | |
| Overall Compliance | ASTM D 3578-05, FDA 21 CFR 880.6250, Labeling Claims | Met | Performs according to standards* |
*Note: The "Conclusion" statement mentions the device "shall perform according to the glove performance standards," implying that studies were conducted to confirm this, as indicated by the "Meets" and "Passes" in the performance column for each characteristic.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each test (e.g., for dimension testing, pinhole testing, etc.). The testing aligns with established ASTM standards (ASTM D 3578-05), which typically outline sampling plans, but the specific numbers are not provided in this 510(k) summary.
Data Provenance: The device manufacturer, Riverstone Resources Sdn. Bhd., is located in Selangor, Malaysia. It is implied that the testing was conducted either internally by the manufacturer or by a contracted laboratory adhering to the specified standards. The data is retrospective in the sense that the tests were performed on finished product batches to demonstrate compliance prior to market approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This is not a study requiring expert interpretation of complex data (like medical images). The "ground truth" here is determined by objective measurements and standardized laboratory tests (e.g., measuring glove dimensions, counting pinholes, chemical analysis for protein content, and biological assays for biocompatibility) according to the specified ASTM and CPSC standards.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective and based on predefined measurement criteria and laboratory procedures, not subjective interpretation requiring adjudication.
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 is a physical medical device (gloves), not an AI/ML powered diagnostic or assistive technology.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (gloves), not an AI/ML algorithm.
7. The Type of Ground Truth Used
The ground truth is based on objective measurements and chemical/biological assay results obtained through standardized laboratory testing procedures as defined by:
- ASTM D 3578-05 (for Dimension, Physical Properties, Freedom from pinholes, Powder-Free, and Protein Content)
- Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 (for Primary Skin Irritation Test)
- ASTM-F 720-81 (Reapproved 2007) (for Dermal Sensitization Assay)
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/ML model that requires a training set. The manufacturing process is controlled to ensure consistent product characteristics that meet the defined standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" in the context of this device's regulatory submission.
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Appendix 2
510(k) Summary Latex Examination Gloves Powder Free
JUL 1 62010
1.0 Submitter:
Company Name: Riverstone Resources Sdn. Bhd.
Company Address: Lot 55, 56, No. 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 Care Latex Examination Gloves Powder Free
Device Name: Latex Patient Examination gloves
Device Classification Name: Patient Examination gloves (21 CFR 880.6250)
Device Class: Class I
Product Code : Latex - LYY
3.0 Identification of The Legally Marketed Device:
Class I patient Examination gloves, Powder Free, LYY which meets all the
requirement of ASTM D 3578-05 and FDA 21 CFR 880.6250.
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4.0 Description of Device
Latex Examination gloves powder free as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LYY (21CFR 880.6250). It meets all the specifications in ASTM D 3578-05, Standard Specification for Latex Examination Gloves. They are made from natural latex compound and powder free.
5.0 Intended use of the Device
Latex Examination gloves powder free is a disposable device intended for medical purpose 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
The powder-free latex examination gloves possess the following technological characteristics compared to ASTM or Equivalent standards:
| Characteristics | Standards | Device Performance |
|---|---|---|
| Dimension | ASTM D 3578-05 | Meets |
| Physical Properties | ASTM D 3578-05 | Meets |
| Freedom from pinholes | ASTM D 3578-05 | Meets |
| Powder-Free | ASTM D 3578-05 | Meets |
| Protein Content | ASTM D 3578-05 | Meets |
| Biocompatibility | Primary Skin Irritation TestConsumer Product SafetyCommission, Title 16, ChapterII, Part 1500 | Passes |
| Dermal Sensitization AssayASTM-F 720-81(Reapproved2007)EI | Passes |
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7.0 Conclusion
It can be concluded that latex examination gloves powder free shall perform according to the glove performance standards references in section 6.0 above and meet ASTM D 3578-05 standard and FDA requirements and the labeling claims for the product.
Prepared by,
Chong Chu Mee Technical Manager Date: 22th Feb 2010.
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a serpent winding around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
JUL 1 62010
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Chong Chu Mee Technical Manager Riverstone Resources SDN. BHD. Lot 55 & 56, Number 15, Jalan Jasmin 2 Kawasan Perindustrian Bukit 48300 Bukit Beruntung Selangor, Malaysia
Re: K100611
Trade/Device Name: RS Care Latex Medical Examination Gloves Powder Free (Non-Sterile) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: June 12, 2010 Received: June 22, 2010
Dear Mr. 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: CDDH, 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 First Register.
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Page 2- Mr. 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/CentersQffices/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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INDICATIONS FOR USE
Applicant: Riverstone Resources Sdn. Bhd. 510(k) Number (if known): K100611
Device Name: RS Care Latex Medical Examination Gloves Powder Free (Non-Sterile)
Indications for Use:
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 Over-The-Counter Use X Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: __ K 1006 l/
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.