(62 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Powdered Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 200 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010).
Acceptance Criteria and Device Performance Study for K120693 - Powdered Latex Patient Examination Glove
This document describes the acceptance criteria and the study demonstrating that the "Powdered Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 200 Micrograms per dm² of glove or Less of Water Extractable Protein)" (K120693) meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance was evaluated against established ASTM standards and ISO standards for biocompatibility.
| Characteristic | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578-05 (2010) | Meets |
| Physical Properties | ASTM D 3578-05 (2010) | Meets |
| Freedom from pin-holes | ASTM D 5151-99 (2006) & ASTM D 3578-05 (2010) | Meets |
| Powder Amount | ASTM D 6124-06 & ASTM D 3578-05 (2010) | Meets |
| Protein Content | ASTM D 5712-10 & ASTM D 3578-05 (2010) | Meets |
| Biocompatibility: | ||
| - Dermal Sensitization | ISO 10993-10:2010 | Not a contact skin sensitizer |
| - Primary Skin Irritation Test | ISO 10993-10:2010 | Not a primary skin irritant |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test or the country of origin for the data. However, the evaluation relies on compliance with established ASTM and ISO standards, which typically involve specific sampling plans and test methods. The studies are non-clinical performance tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. For this type of medical device (patient examination gloves), the "ground truth" is established by adherence to recognized national and international consensus standards (ASTM and ISO), not by expert consensus on clinical data or image interpretation. The tests are laboratory-based and objective measurements.
4. Adjudication Method for the Test Set
Not applicable. The performance testing involves objective measurements against established standard specifications, not subjective interpretation requiring adjudication among experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a patient examination glove, and its performance is assessed through non-clinical laboratory testing against physical, chemical, and biocompatibility standards. MRMC studies are typically relevant for diagnostic imaging or similar devices that involve human interpretation of results.
6. Standalone Performance Study
Yes, a standalone (algorithm only without human-in-the-loop performance) study was done in the sense that the device itself, a physical product, was subjected to a series of laboratory tests to evaluate its inherent characteristics against the specified standards. Human interaction is limited to conducting the tests according to the standard protocols and recording the objective results.
7. Type of Ground Truth Used
The ground truth used is based on established national and international consensus standards (ASTM and ISO). These standards define objective pass/fail criteria and test methodologies for dimensions, physical properties, freedom from pinholes, powder amount, protein content, and biocompatibility.
8. Sample Size for the Training Set
Not applicable. This device is a physical product, not an algorithm or AI model that requires a training set. The evaluation is based on direct testing of the manufactured product batches against standardized criteria.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this device. The ground truth for evaluating the device's performance is established by the specified ASTM and ISO standards themselves, which outline the acceptable ranges and test methods.
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K120093
TOP CALIBRE SDN. BHD.
- WAY. -- 8 2012
FDA 510(k), Premarket Notification: 510(k) Summary of Safety and Effectiveness Information
Date: 11 April 2012
1.0 Submitter:
Top Calibre Sdn Bhd 1-1, 2, Jalan Setia Prima U13/S Setia Alam, Seksyen U13, 40170 Shah Alam, Selangor, Malaysia
Telephone No .: 4603 3291 0516 +603 3291 0542 Fax No.:
2.0 Contact Person:
| Contact: | Ms Tracy Ngui |
|---|---|
| Telephone No.: | +603 3291 0516 |
| Fax No.: | +603 3291 0542 |
Name of Device: 3.0
Trade Name: Powdered Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 200 Micrograms per dm- of glove or Less of Water Extractable Protein) Patient Examination Glove Common Name:
Classification Name: Patient Examination Glove
4.0 Identification of the Legally Marketed Device:
Powdered Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 200 Micrograms per dm2 of glove or Less of Water Extractable Protein), Class I patient examination gloves, Latex - 80LYY, meets all of the requirements of ASTM D3578-05 (2010) Standard Specification for Rubber Examination Glove.
Predicate Device: K003737, Powdered Latex Patient Examination Glove, With Protein Content Labeling Claim (Contains 200 Micrograms per dm2 of glove or Less of Water Extractable Protein)
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TOP CALIBRE SDN. BHD.
Description of Device: 5.0
Powdered Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 200 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010).
6.0 Intended Use of the Device:
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Summary of the Technological Characteristics of the Device: 7.0
Powdered Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 200 Micrograms per dm² of glove or Less of Water Extractable Protein) possesses the following technological characteristic (as compared to ASTM or equivalent standards):
| Characteristic | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578-05(2010) | Meets |
| Physical Properties | ASTM D 3578-05(2010) | Meets |
| Freedom from pin-holes | ASTM D 5151-99(2006) | Meets |
| ASTM D 3578-05(2010) | ||
| Powder Amount | ASTM D 6124-06 | Meets |
| ASTM D 3578-05(2010) | ||
| Protein Content | ASTM D 5712-10 | Meets |
| ASTM D 3578-05(2010) | ||
| Biocompatibility | Dermal Sensitization(as ISO 10993-10:2010) | Not a contact skin sensitizer |
| Primary SkinIrritation Test(as ISO 10993-10:2010) | Not a primary skin irritant |
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TOP CALIBRE SDN. BHD.
Substantial Equivalent Based on Assessment of Non-Clinical Performance 8.0 Data
The performance test data that support a determination of substantial equivalence are described above.
Substantial Equivalent Based on Assessment of Clinical Performance Data 9.0
. Clinical data is not needed for market cleared examination gloves.
10.0 Conclusion
It can be concluded that the Powdered Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 200 Micrograms per dm2 of glove or Less of Water Extractable Protein), is safe and effective for use with chemotherapeutic agents and will perform according to the glove performance standards referenced in Section 7.0 above, thereby meeting ASTM standards, FDA requirements, and the labeling claims for the product.
The device comparison below outlines the similarity, and/or differences between the proposed device and the predicate device for the substantial equivalent determination.
| Characteristics | Predicate Device | Proposed Device |
|---|---|---|
| K003737, Powdered LatexPatient Examination Glove withProtein Content Labeling Claim(200 Micrograms per gram ofglove less) | Powdered Latex PatientExamination Glove, with ProteinContent Labeling Claim(Contains 200 Micrograms perdm² of glove or less of WaterExtractable Protein) | |
| Device Description/Regulation Number | Patient Examination Glove/21 CFR Part 880.6250 | Identical |
| Product Code | 80 LYY | Identical |
| Intended Use | Intended for medical purposesthat is worn on the examiner'shand to prevent contaminationbetween patient and examiner. | Identical |
| Indications for Use | A patient examination glove is adisposable device intended formedical purposes that is wornon the examiner's hand toprevent contamination betweenpatient and examiner. | Identical |
| Characteristics | Predicate Device | Proposed Device |
| PowderedLatexK003737, | Powdered Latex Patient | |
| Patient Examination Glove with | Examination Glove, with Protein | |
| Protein Content Labeling Claim | Content Labeling Claim | |
| (200 Micrograms per gram of | (Contains 200 Micrograms per | |
| glove less) | dm2 of glove or less of Water | |
| Extractable Protein) | ||
| Design | Ambidextrous, in different sizesper ASTM D3578 dimensionrequirement | Identical |
| Materials | Natural Rubber Latex | Identical |
| Color | Natural Color | Identical |
| Performance | Not Applicable (Non-Sterile) | Identical |
| SterilityI.Freedom fromII. | Meets ASTM D3578 | Identical |
| holes | ||
| DimensionIII. | Meets ASTM D3578 | Identical |
| PhysicalIV.Properties | Meets ASTM D3578 | Identical |
| V.PowderAmount | Meets ASTM D3578 | Identical |
| VI--Protein | Meets-ASTM-D3578 | Identical- |
| Content | ||
| Single Use | Yes | Identical |
| Biocompatibility | Passes | |
| Test | i. Primary Skin Irritation Test | Identical |
| ii. Dermal Sensitization Test | Identical | |
| Packaging | Packed in Dispenser Boxes | Identical |
| Labeling Claim | ExtractableProteinWithContent Labeling Claim | Identical |
Substantial Equivalence Comparison Table
Page 3 of 4 (Revision 1)
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TOP CALIBRE SDN. BHD.
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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol of medicine and healing, featuring a staff with two snakes coiled around it. The caduceus is oriented diagonally, pointing upwards and to the right.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Tracy Ngui Quality Assurance Manager Top Calibre Sdn. Bhd 1-1, 2, Jalan Setia Prima U13/S Setia Alam, Seksyen U13, 40170 Shah Alam, Selangor, MALAYSIA
MAY - 8 2012
Re: K120693
Trade/Device Name: Powdered Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 200 Micrograms per dm2 of Glove or Less of Water Extractable Protein) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: April 11, 2012 Received: April 12, 2012
Dear Ms. Tracy Ngui:
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. Ngui
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 ucm 1 15809.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.html 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. Owens
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
510(k) Number (if known):
Powdered Latex Patient Examination Gloves with Protein Content labeling Claim Device Name: (Contains 200 Micrograms per dm2 of glove or Less of Water Extractable Protein)
Indications for Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C) X
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
Elizabetk. F-Clunie-Willen
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of
510(k) Number: K120693
§ 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.