(204 days)
The Examination gloves-Type A (Latex 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 proposed device, The Examination gloves-Type A ( Latex 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 proposed device is made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is provided non-sterile and the shelf life is 5 years.
This document is a 510(k) summary for Examination gloves-Type A (Latex gloves). It details the device's characteristics, intended use, and a comparison to a predicate device, along with non-clinical performance test data to demonstrate substantial equivalence.
Here's an analysis of the provided information, focusing on acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
| Test Item | Test Standard | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|---|
| Dimension | ASTM D3578-19 | Length: Min 230 mm for all sizes. Width: Small: 80 ± 10 mm, Medium: 95 ± 10 mm, Large: 111 ± 10 mm. Thickness: Palm: 0.08 mm min, Finger: 0.08 mm min. | Length: S: 240-244mm, M: 241-245mm, L: 242-245mm. Width: S: 84-86mm, M: 96-98mm, L: 105-108mm. Thickness: Palm: 0.11-0.13mm, Finger: 0.13-0.14mm. | Pass |
| Physical Properties - Tensile Strength | ASTM D3578-19 | Before Ageing: 18 MPa Minimal for all sizes. After Ageing: 14 MPa Minimal for all sizes. | Before Ageing: 20.6 MPa Min. After Ageing: 18.9 MPa Min. | Pass |
| Physical Properties - Ultimate Elongation | ASTM D3578-19 | Before Ageing: 650% Min for all sizes. After Ageing: 500% Min for all sizes. | Before Ageing: 683% Min. After Ageing: 623% Min. | Pass |
| Watertight test | ASTM D5151-19 | Sample size: 200 pcs, Inspection level: GI, AQL 1.5, Acceptance Number 7, Rejection Number 8. | Sample size: 200 pcs, Inspection level: GI, AQL 1.5, Result: 0. | Pass |
| Residual powder | ASTM D6124-06 (Reapproved 2017) | 2 mg per glove or less. | 0.02 mg per glove. | Pass |
| Protein content | ASTM D5712-15 | 200 µg/dm² Max for all sizes. | 75 µg/g. | Pass |
| Skin Sensitization | ISO 10993-10 | Under the conditions of the study not a sensitizer. | Non-sensitizing. | Pass |
| Irritation | ISO 10993-10 | Under the condition of study not an irritant. | Non-irritating. | Pass |
| Systemic toxicity | ISO 10993-11:2017 | Under the conditions of study the device extracts do not pose a systemic toxicity concern. | Non-systemic toxicity. | Pass |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Watertight test: 200 pieces (gloves).
- Sample Size for other tests: The document specifies "Minimal for all sizes" or "for all sizes" without providing explicit sample counts for each specific physical and chemical test.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. All submissions are from China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is a physical medical device (examination gloves), not an AI/software device that requires expert adjudication for ground truth related to image interpretation or diagnosis. The "ground truth" for these tests is established by standardized methods and measurements as defined by ASTM and ISO standards, not by expert consensus. Therefore, this question is not applicable in the context of these non-clinical performance tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in AI/imaging studies where there might be inter-reader variability. For the physical and chemical tests conducted on examination gloves, the determination of pass/fail is based on objective measurements against predefined acceptance criteria from international standards. There is no mention of an adjudication method as it is not relevant to this type of testing.
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
This question is not applicable. The device in question is examination gloves, not an AI-assisted diagnostic tool. Therefore, MRMC studies or assessments of human reader improvement with AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical product (examination gloves), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests on these examination gloves is based on:
- Standardized measurement and testing protocols: Adherence to established international standards (ASTM and ISO).
- Objective physical and chemical properties: Measurements of dimensions, tensile strength, elongation, residual powder, protein content, and biological reactivity (skin sensitization, irritation, systemic toxicity).
- Defined Pass/Fail criteria: Each test has specific numerical or qualitative acceptance criteria derived from the respective standard.
8. The sample size for the training set
This question is not applicable. The 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
This question is not applicable for the same reason as in point 8.
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July 14, 2022
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd % Alice Huang RA Manager Shanghai Mind-link Business Consulting Co., Ltd. Room 8208, Second Floor, No 1399, Jiangyue Road Minhang District Shanghai. 201114 China
Re: K214017
Trade/Device Name: Examination gloves-Type A(Latex gloves) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYY Dated: June 14, 2022 Received: June 21, 2022
Dear Alice Huang:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bifeng Qian, M.D., Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K214017
Device Name
Examination gloves-Type A (Latex gloves)
Indications for Use (Describe)
The Examination gloves-Type A (Latex 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary K214017
I. SUBMITTER:
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. No. 316 National road. Xinju, Changshan Town. Jinxian County, Nanchang City, Jiangxi Province, China. Contact Person: Jenny Huang TITEL: International Trade Supervisor TEL: +86 17702094798 Email: sales@jxkmjt.com
Submission Correspondent: Alice Huang Email: alice.huang@mind-link.net Tel:+86 15618536177 Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District, Shanghai
Summary prepared: 07/12/2022
II. DEVICE
Name of Device: Examination gloves-Type A(Latex gloves) Regulation Number: 21 CFR 880.6250 Common Name: Latex patient examination glove Classification Name: Nonpowdered patient examination glove Regulatory Class: I Product Code: LYY
III. PREDICATE DEVICE 510(k) Number: K173053 Product Name: Powder Free Latex Examination Glove Manufacture: Professional Latex Sdn Bhd
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IV. DEVICE DESCRIPTION
The proposed device, The Examination gloves-Type A ( Latex 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 proposed device is made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is provided non-sterile and the shelf life is 5 years.
V. INDICATIONS FOR USE
The Examination gloves-Type A(Latex 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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| DEVICE | Subject Device(K214017) | Primary Predicate Device(K173053) | Comparison |
|---|---|---|---|
| Intended Use | The Examination gloves-Type A(Latex gloves) is a disposabledevice intended for medicalpurposes that is worn on theexaminer's hand or finger toprevent contamination betweenpatient and examiner. | A patient examination gloves is adisposable device intended formedical purpose that is worn onthe examiner's hand or finger toprevent contamination betweenpatient and examiner | Same |
| ClassificationProduct Code | LYY | LYY | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | Class I | Class I | Same |
| Powderedor | Powdered free | Powdered free | Same |
The subject device.
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| Powdered free | |||||
|---|---|---|---|---|---|
| Material | Natural Rubber Latex | Natural Rubber Latex | Same | ||
| Color | No colour pigment added.Natural White | No colour pigment added.Natural White | Same | ||
| Dimensions | Length:S: 240-244mmM: 241-245mmL: 242-245mmWidth:S: 84-86mmM: 96-98mmL: 105-108mmPalm Thickness: 0.11-0.13mmFinger Thickness: 0.13-014mm | Length:Average:242mmWidth:Average:S:85mmM:95mmL:104mmPalm Thickness: Average:0.09Finger Thickness:Average:0.11 | SimilarMeetingrequirementof ASTMD 3578 | ||
| Biocompatibility | Non-sensitizingNon-irritatingNon-systemic toxicity | Non-sensitizingNon-irritating | SimilarMeetingrequirementof ISO 1099 | ||
| Tensilestrength | Before Aging | 20.6MPa, min | Before Aging | 23.65MPa | Similar |
| Stress at 500 %Elongation | 5.1MPa, max | Stress at 500 %Elongation | 3.5MPa | Meetingrequirementof ASTMD 3578 | |
| After Aging | 18.9MPa, min | After Aging | 20.99MPa | ||
| UltimateElongation | Before Aging | 683%, min | Before Aging | 734% | |
| After Aging | 623%,min | After Aging | 622% | ||
| Freedom fromHoles | Meets ASTM D5151-19 | Meets ASTM D5151-19 | Same | ||
| ProteinContent | Meets ASTM D5712-2015 | Meets ASTM D5712-2015 | Same | ||
| Powderedresidue | Meets ASTMD6124-06(Reapproved 2017) | Meets ASTMD6124-06(Reapproved 2017) | Same | ||
| Sterility | Non-sterile | Non-sterile | Same | ||
| Single Use | YES | YES | Same | ||
| Label andlabeling | Meet FDA's Requirement | Meet FDA's Requirement | Same |
VII. SUMMARY OF NON-CLINICAL PERFORMANCE TEST DATA
| Test item | Test standard | Acceptance Criteria | Test result | Conclusion |
|---|---|---|---|---|
| Dimension | ASTMD3578-19 | Length:Min 230 mm for all sizes | Length:S:240-244mmM:241-245mm | Pass |
| L:242-245mm | ||||
| ASTMD3578-19 | Width:Small: 80 ± 10 mmMedium: 95±10mmLarge: 111± 10 mm | Width:S: 84-86mmM:96-98mmL:105-108mm | Pass | |
| ASTMD3578-19 | Thickness:Palm: 0.08 mm minFinger: 0.08 mm min | Thickness:Palm:0.11-0.13mmFinger: 0.13-014mm | Pass | |
| Physical Properties-Tensile strength | ASTMD3578-19 | Before AgeingTensile Strength: 18MpaMinimal for all sizesAfter Ageing TensileStrength 14MpaMinimal for all sizes | Before AgeingTensile Strength:20.6Mpa MinAfter AgeingTensile Strength18.9Mpa Min | Pass |
| Physical Properties-Ultimate Elongation | ASTMD3578-19 | Before AgeingUltimate Elongation:650% Min for all sizesAfter AgeingUltimate Elongation500% Min for all sizes | Before AgeingUltimate Elongation:683% MinAfter AgeingUltimate Elongation623% Min | Pass |
| Watertight test | ASTMD5151-19 | Sample size: 200 pcsInspection level : GIAQL 1.5Acceptance Number 7Rejection Number 8 | Sample size: 200 pcsInspection level : GIAQL 1.5Result:0 | Pass |
| Residual powder | ASTMD6124-06 | 2 mg per glove or less | 0.02mg per glove | Pass |
| Protein content | ASTM D5712- 15 | 200 µg/dm² Max for allsizes | 75ug/g | Pass |
| Skin Sensitization | ISO 10993-10 | Under the conditionsof the study not asensitizer | Non-sensitizing | Pass |
| Irritation | ISO 10993-10 | Under the condition ofstudy not an irritant | Non-irritating | Pass |
| Systemic toxicity | ISO 10993-11:2017 | Under the conditions ofstudy the device extractsdo not pose a systemictoxicity concern | Non-systemictoxicity | Pass |
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- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
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- ASTM D3578-19 Standard Specification for Rubber Examination Gloves ●
- ASTM D5712-15 Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
- ASTM D7160 Standard Practice for Determination of Expiration Dating for medical Gloves
- ASTM D7161 Standard Practice for Determination of Expiration Date of Medical Gloves
- . ISO 10993-1 : 2009 Biological evaluation of medical devices - Part1: Evaluation and testing within a risk management process
- ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- ISO 10993-11:2017 Biological Evaluation of Medical Devices - Part 5: Tests For systemic toxicity
- ISO 15233-1-2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied
VIII. CONCLUSION
The Conclusion drawn from the Non-Clinical test demonstrates that the subject device, Examination gloves-Type A (Latex gloves) is as safe, as effective, and performs as well as or better than the legally marketed Predicate device cleared under K173053.
§ 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.