(123 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
The Powder Free Nitrile (Black) Examination Gloves meets all the requirements of ASTM Specification D6319-10 -Standard Specification for Nitrile Examination Gloves for Medical Application.
The provided text describes the acceptance criteria and performance of "Powder Free Nitrile (Black) Examination Gloves" by Gallant Quality SDN. BHD. It is a 510(k) premarket notification, indicating a claim of substantial equivalence to a legally marketed predicate device.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D6319-10: Length - min. 230mm, Width - min. 95 ± 10mm (for predicate, proposed specifies ranges for each size) | Meets ASTM D6319-10 Standard requirements:Minimal value for Length: 242 mmMinimal value for Width: 94mmPalm - min. 0.09mmFinger - min. 0.13mm |
| Physical Properties (Tensile Strength) | ASTM D6319-10: Before Aging: 14 MPa, After Aging: 14 MPa | Meets ASTM D6319-10 Standard requirements:Before Aging: Minimal Value: 24.74 MPaAfter Accelerated Aging: Minimal Value: 31.67 MPa |
| Physical Properties (Ultimate Elongation) | ASTM D6319-10: Before Aging: min. 500%, After Aging: min. 400% | Meets ASTM D6319-10 Standard requirements:Before Aging Minimal Value: 528%After Aging Minimal Value: 439% |
| Thickness | ASTM D6319-10: Min 0.05mm | Meets standard requirements:Palm - min. 0.09mmFinger - min. 0.13mm |
| Biocompatibility (Irritation) | ISO 10993-10:2010: Tests for irritation | Under the condition of the Study - Not an irritant |
| Biocompatibility (Skin Sensitization) | ISO 10993-10:2010: Tests for skin sensitization | Under the condition of the Study - Not a sensitizer |
| Freedom from Pinholes | 21 CFR 800.20; ASTM D5151-06: AQL 2.5 | Meets 21 CFR 800.20 and ASTM D5151 – 06 Standard Requirements; Passes AQL 2.5 |
| Powder Residual | ASTM D6124-06: ≤ 2 mg/ glove | Meets ASTM D6124-06 Standard requirements; Minimal Value: 0.32 mg |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each test. It states that the device performance "meets ASTM D6319-10 Standard requirements" or similar phrases, implying that testing was conducted according to those standards, which would typically define sample sizes.
The data provenance is from Malaysia, as the submitter (Gallant Quality SDN. BHD.) is located in Taiping, Perak, Malaysia. The study appears to be retrospective, as it presents the results of tests already conducted, demonstrating compliance with established standards for the purpose of a 510(k) submission.
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. For medical gloves, ground truth is typically established through direct physical and chemical testing against a consensus standard (like ASTM or ISO), rather than human expert opinion on images or clinical cases. The "experts" would be the laboratory personnel performing the standardized tests, and their qualifications would be adherence to the test methodologies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the evaluations are based on objective physical, chemical, and biological tests according to established standards (ASTM, ISO, CFR), not subjective assessments requiring adjudication by multiple readers.
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
No, a multi-reader multi-case comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI-assisted diagnostic tools, not for medical examination gloves.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This device is a physical medical glove and does not involve any algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used is based on consensus standards and regulatory requirements, specifically:
- ASTM D6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application.
- ISO 10993-10:2010: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.
- 21 CFR 800.20: Regulations regarding general requirements for examination gloves.
- ASTM D5151-06: Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06: Standard Test Method for Residual Powder on Medical Gloves.
These standards define the acceptable physical properties, biocompatibility, and integrity for medical examination gloves.
8. The sample size for the training set
Not applicable. This device is a physical product (medical glove) and does not involve machine learning models that require training sets.
9. How the ground truth for the training set was established
Not applicable. As stated in point 8, there is no training set for this type of device.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of three faces in profile, stacked on top of each other. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 9, 2015
Gallant Quality SDN. BHD. Ms. Sumathi Saravana Sami Assistant QA Manager Lot 1874. Jalan Kampung Dew 34700 Taiping, Perak MALAYSIA
Re: K151528
Trade/Device Name: Powder Free Nitrile (Black) Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Regulatory Class: I Product Code: LZA Dated: September 3, 2015 Received: September 9, 2015
Dear Ms. Sumathi Saravana Sami:
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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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiologic Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K151528
Device Name
Powder Free Nitrile (Black) Examination Gloves
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY K151528
1.0 Submitter :
| Name | : Gallant Quality Sdn. Bhd. |
|---|---|
| Address | : Lot 1874, Jalan Kampung Dew,34700 Taiping, Perak,Malaysia |
| Phone No. | : 605-847 2777 |
| Fax No . | : 605-847 9108 |
Contact Person : Sumathi Saravana Sami (Ms) : sumathisaravana@comfort-rubber.com.my Email 28 September 2015 Date of Preparation:
2.0 Name of the Device
Powder Free Nitrile (Black) Examination Gloves
| Common Name | Nitrile Exam Gloves |
|---|---|
| Classification Name | Patient Examination Gloves (21 CFR 880.6250) |
| Product Code | LZA |
3.0 Identification of The Legally Marketed Devices That equivalency is claimed:
Primary Predicate:
Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) Company: Worldmed Manufacturing Sdn. Bhd. 510(k): K123116 Regulatory Class I Product Code: LZA
4.0 Description of the Device:
The Powder Free Nitrile (Black) Examination Gloves meets all the requirements of ASTM Specification D6319-10 -Standard Specification for Nitrile Examination Gloves for Medical Application.
5.0 Intended Use of the Device
The Powder Free Nitrile (Black) Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
6.0 Summary of the Technological Characteristics of the Device:
The Powder Free Nitrile (Black) Examination Gloves are summarized with the following technological characteristics and is substantially equivalent to the predicate device with regard to physical characteristics, design, product features, and intended use. Both gloves
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are made with nitrile and meets ASTM Specification D6319-10 - Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D6319-10:Length - min. 230mmWidth - min. 95 ± 10mm | Meets ASTM D6319-10Standard requirementsMinimal value for Length:242 mmMinimal value for Width: 94mm |
| Physical Properties | ASTM D6319-10:Tensile Strength:Before Aging: 14 MPaAfter Aging: 14 MPA | Meets ASTM D6319-10Standard requirementsTensile Strength:Before Aging: Minimal Value:24.74 MPaAfter Accelerated Aging:Minimal Value: 31.67 MPa |
| Ultimate Elongation:Before Aging: min. 500%After Aging: min. 400% | Ultimate Elongation:Before Aging Minimal Value:528%After Aging Minimal Value:439% | |
| Thickness | ASTM D6319-10Min 0.05mm | Meets standard requirementsStandard requirementsPalm - min. 0.09mmFinger - min. 0.13mm |
| Biocompatibility | ISO 10993-10:2010Biological evaluation ofmedical devices – Part 10:Tests for irritation and skinsensitization | Under the condition of theStudy - Not an irritant |
| ISO 10993-10:2010Biological evaluation ofmedical devices – Part 10:Tests for irritation and skinsensitization | Under the condition of theStudy - Not a sensitizer | |
| Freedom from Pinholes | 21 CFR 800.20; ASTMD5151-06AQL 2.5 | Meets 21 CFR 800.20 andASTM D5151 – 06 StandardRequirementsPasses AQL 2.5 |
| Powder Residual | ASTM D6124-06:$\le$ 2 mg/ glove | Meets ASTM D6124-06Standard requirementsMinimal Value: 0.32 mg |
7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data
The performance test data of non-clinical tests that support a determination of substantial equivalence is the same as described in section 6.0 above and meets ASTM standards, and FDA requirements for water leak test on pinhole AQL.
8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data
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Not applicable - Clinical data is not needed for gloves or most devices cleared by the 510(k) process.
9.0 Substantial Equivalence Comparison
The Powder Free Nitrile (Black) Examination Gloves is substantially equivalent to the predicate device with respect to intended use, product features and the technological characteristics. The substantial equivalence comparison is presented in the table below:
| Characteristicandparameters | WorldmedManufacturing Sdn.Bhd. K123116(Predicate) | Powder Free Nitrile(Black) ExaminationGloves(Proposed) | SubstantialEquivalence(SE) |
|---|---|---|---|
| Product Code | LZA | LZA | SE |
| Intended use | Intended for medicalpurposes that is worn onthe examiner's hands orfingers to preventcontamination betweenpatient and examiner. | Intended for medicalpurposes that is worn onthe examiner's hands orfingers to preventcontamination betweenpatient and examiner. | SE |
| Indications forUse Statement | The nitrile examinationglove is a disposabledevice intended formedical purpose that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner | The Powder Free Nitrile(Black) ExaminationGloves is a disposabledevice intended formedical purposes that isworn on the examiner'shands or fingers toprevent contaminationbetween patient andexaminer. | SE |
| Device Material | Nitrile Synthetic Latex | Nitrile Synthetic Latex | SE |
| Color | Black | Black | SE |
| Additives | No flavor additive | No flavor additive | SE |
| Instruction forUse on Labeling | Single Use Only | Single Use Only | SE |
| Construction | Ambidextrous | Ambidextrous | SE |
| Sterility | Non-sterile | Non-sterile | SE |
| AcceptanceCriteria | ASTM D6319-10 | ASTM D6319-10 | SE |
| Device Tolerance & Specifications: | |||
| Dimensions | Meets ASTM D 6319-10 | Meets ASTM D 6319-10Overall Length – min. 230mmWidth(±10mm)Size XS – 70mmSize S - 80mmSize M - 95mmSize L - 110mm | SE |
| Size XL-120mm | |||
| Thickness at Finger - min. 0.05mmThickness at Palm - min. 0.05mm | Thickness at Finger - min. 0.05mmThickness at Palm - min. 0.05mm | ||
| PhysicalProperties | Meets ASTM D6319-10: | Meets ASTM D6319-10: | SE |
| Before AgingTensile strength - min.14.0 MPaUltimate Elongation - min. 500% | Before AgingTensile strength - min.14.0 MPaUltimate Elongation - min. 500% | ||
| After AgingTensile Strength - min14.0 MPaUltimate Elongation - min. 400% | After AgingTensile Strength - min14.0 MPaUltimate Elongation - min. 400% | ||
| BiocompatibilityTesta. IrritationTestsb. SkinSensitizationTests | Under the conditions of the study, not an irritant and contact non-sensitizer. | Under the conditions of the study, not an irritant and contact non-sensitizer. | SE |
| ResidualPowder Test | Meets ASTM D6124-06:$\le$ 2 mg/ glove | Meets ASTM D6124-06:$\le$ 2 mg/ glove | SE |
| Freedom from | Meets ASTM D5151-06 | Meets ASTM D5151-06 | SE |
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10.0 Conclusion
The Powder Free Nitrile (Black) Examination Gloves meet all of the requirements of FDArecognized consensus standards: ASTM D6319-10, ASTM D5151-06, ASTM D6124-06 and ISO 10993-10:2010 and meet our labeling claims and pinhole acceptable quality level (AQL) as shown above.
There are no significant differences between the two products and are identical in terms of intended use, materials and performance.
The conclusion drawn from the nonclinical tests demonstrate that the device is as safe and as effective and performs as well as the legally marketed device.
Based on the comparison of intended use, design, device materials, performance and specification, the Powder Free Nitrile (Black) Examination Gloves are substantially equivalent to the predicate device.
§ 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.