(68 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.
Powder Free Latex Patient Examination Glove, with Protein Content Labeling Claim, Chlorinated (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010).
The provided text is for a 510(k) Premarket Notification for a medical device, specifically a Powder Free Latex Patient Examination Glove. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance data and comparison of technological characteristics, rather than extensive clinical studies as one might find for a novel diagnostic AI device.
Therefore, many of the typical acceptance criteria and study details requested (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of device and submission. The "study" here refers to the testing performed to meet specific ASTM standards and biocompatibility requirements.
Here's a breakdown of the information that is applicable and how it relates to the acceptance criteria:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are defined by existing ASTM standards and biocompatibility testing. The device's performance is reported as meeting these standards.
| 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 Free Residue | 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 |
| Biocompatibility (Primary Skin Irritation) | ISO 10993-10:2010 | Not a primary skin irritant |
| Intended Use | Disposable device for medical purposes, worn on examiner's hand to prevent contamination between patient and examiner. | Identical to predicate device |
| Regulation Number | 21 CFR Part 880.6250 | Identical to predicate device |
| Product Code | 80 LYY | Identical to predicate device |
| Design | Ambidextrous, in different sizes per ASTM D3578 dimension requirement. | Identical to predicate device |
| Materials | Natural Rubber Latex | Identical to predicate device |
| Color | Natural Color | Identical to predicate device |
| Sterility | Not Applicable (Non-Sterile) | Identical to predicate device |
| Single Use | Yes | Identical to predicate device |
| Packaging | Packed in Dispenser Boxes | Identical to predicate device |
| Labeling Claim | With Extractable Protein Content Labeling Claim (50 Micrograms per dm² of glove or less of Water Extractable Protein) | Identical to predicate device |
2. Sample size used for the test set and the data provenance
The document specifies that the device "meets all the current specification for ASTM D3578-05 (2010)" and refers to other ASTM and ISO standards for specific characteristics. Clinical data was "not needed for market cleared examination gloves."
- Sample Size for Test Set: The specific sample sizes for each test (e.g., pin-holes, dimensions, physical properties) are not detailed in this 510(k) summary. These would typically be specified within the individual ASTM and ISO standards referenced. For example, ASTM D5151-99 for freedom from pinholes often specifies a sample size based on the acceptable quality level (AQL).
- Data Provenance: The document does not explicitly state the country of origin for the data (e.g., where the tests were physically conducted) nor whether it was retrospective or prospective. Given the nature of performance testing against standards, it would be prospective testing of newly manufactured glove batches. The manufacturer is "Top Calibre Sdn Bhd" in Selangor, Malaysia, so the testing was likely conducted by or for them.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable: This type of device does not involve a "ground truth" established by experts in a diagnostic or interpretive sense. The ground truth for performance characteristics is defined by the objective measurement criteria within the relevant ASTM and ISO standards (e.g., tensile strength, elongation, water leak rate, protein content measurement). Biocompatibility tests are performed by qualified laboratories and assessed against established toxicology criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable: Adjudication methods like 2+1 or 3+1 are used for human-reviewed data, often in diagnostic imaging or clinical trials, to resolve discrepancies between readers. For physical and chemical tests of gloves, results are objectively measured against defined thresholds in the standards; there is no 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 device is a patient examination glove, not an AI-powered diagnostic tool. Therefore, MRMC studies and assessments of AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable: This device is a physical medical device (glove), not an algorithm or software. Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by objective measurements against predefined criteria and thresholds set forth in the referenced ASTM and ISO standards.
- For Dimensions, Physical Properties, Freedom from pin-holes, Powder Free Residue, Protein Content: The ground truth is the quantitative measurement of these properties (e.g., thickness, tensile strength, percentage of gloves passing water leak test, specific protein content in µg/dm²) compared to the specified limits in standards like ASTM D3578-05 (2010), ASTM D5151-99 (2006), ASTM D6124-06, and ASTM D5712-10.
- For Biocompatibility: The ground truth is determined by the results of standardized biological tests (Dermal Sensitization and Primary Skin Irritation Tests as per ISO 10993-10:2010), which assess the device's potential to cause adverse biological reactions. The "ground truth" in this context is the observation of whether a reaction occurs and its severity, interpreted against established toxicity criteria, leading to a "pass" or "fail" determination (e.g., "Not a contact skin sensitizer," "Not a primary skin irritant").
8. The sample size for the training set
Not Applicable: This device does not use machine learning or AI, so there is no "training set."
9. How the ground truth for the training set was established
Not Applicable: As there is no training set, this question is not relevant.
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MAY 1 4 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
+603 3291 0516 Telephone No .: +603 3291 0542 Fax No.:
2.0 Contact Person:
| Contact: | Ms Tracy Ngui |
|---|---|
| Telephone No .: | +603 3291 0516 |
| Fax No .: | +603 3291 0542 |
3.0 Name of Device:
Trade Name: Powder Free Latex Patient Examination Glove, with Protein Content Labeling Claim, Chlorinated (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)
Common Name: Patient Examination Glove Classification Name: Patient Examination Glove
4.0 Identification of the Legally Marketed Device:
Powder Free Latex Patient Examination Glove, with Protein Content Labeling Claim, Chlorinated (Contains 50 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: K062917, Non-Sterile Powder Free Latex Patient Examination Glove, With Extractable Protein Content Labeling Claim (50 Micrograms per gram of glove or Less).
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5.0 Description of Device:
Powder Free Latex Patient Examination Glove, with Protein Content Labeling Claim, Chlorinated (Contains 50 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.
7.0 Summary of the Technological Characteristics of the Device:
Powder Free Latex Patient Examination Glove, with Protein Content Labeling Claim, Chlorinated (Contains 50 Micrograms per dm4 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)ASTM D 3578-05(2010) | Meets |
| Powder Free Residue | ASTM D 6124-06ASTM D 3578-05(2010) | Meets |
| Protein Content | ASTM D 5712-10ASTM D 3578-05(2010) | Meets |
| Biocompatibility | Dermal Sensitization(as ISO 10993-10:2010)Primary SkinIrritation Test(as ISO 10993-10:2010) | Not a contact skin sensitizerNot a primary skin irritant |
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8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance 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 Powder Free Latex Patient Examination Glove, with Protein Content Labeling Claim, Chlorinated (Contains 50 Micrograms per dmof 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 |
|---|---|---|
| K062917, Non-Sterile PowderFree Latex Patient ExaminationGlove, with Extractable ProteinContent Labeling Claim (50Micrograms per gram of gloveor less) | Powder Free Latex PatientExamination Glove, with ProteinContent Labeling Claim,Chlorinated (Contains 50Micrograms per dm² of glove orless of Water Extractable 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 |
| K062917, Non-Sterile PowderFree Latex Patient ExaminationGlove, with Extractable ProteinContent Labeling Claim (50Micrograms per gram of gloveor less) | Powder Free Latex PatientExamination Glove, with ProteinContent Labeling Claim,Chlorinated (Contains 50Micrograms per dm² of glove orless of Water Extractable Protein) | |
| Design | Ambidextrous, in different sizesper ASTM D3578 dimensionrequirement. | Identical |
| Materials | Natural Rubber Latex | Identical |
| Color | Natural Color | Identical |
| PerformanceI. Sterility | Not Applicable (Non-Sterile) | Identical |
| II. Freedom fromholes | Meets ASTM D3578 | Identical |
| III. Dimension | Meets ASTM D3578 | Identical |
| IV. PhysicalProperties | Meets ASTM D3578 | Identical |
| V. Powder FreeResidue | Meets ASTM D3578 | Identical |
| VI. ProteinContent | Meets ASTM D3578 | Identical |
| Single Use | Yes | Identical |
| BiocompatibilityTest | Passesi. Primary Skin Irritation Testii. Dermal Sensitization Test | Identical |
| Packaging | Packed in Dispenser Boxes | Identical |
| Labeling Claim | With Extractable ProteinContent Labeling Claim | Identical |
Substantial Equivalence Comparison Table
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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 two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. The symbol on the right is a stylized representation of a human figure, possibly suggesting care or support.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Tracy Ngui Ouality Assurance Manager Top Calibre Sdn. Bhd 1-1, 2, Jalan Setia Prima U13/S Setia Alam, Seksyen U13, 40170 Shah Alam, Selangor, MALAYSIA
MAY 1 4 2012
Re: K120692
Trade/Device Name: Powder Free Latex Examination Glove with Protein Content Labeling Claim, Chlorinated, (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)
Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: April 11, 2012 Received: April 12, 2012
Dear Ms. 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 (OS) 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
cam Anthur
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 Healthealth
Enclosure
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Indications for Use
510(k) Number (if known):
Powder Free Latex Patient Examination Glove, with Protein Content Labeling Claim, Chlorinated, Device Name: (Contains 50 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)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
Elizabeth F. Clavint-Willens
Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K120692
§ 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.