Examination gloves-Type A(Latex gloves)
Device Facts
| Record ID | K214017 |
|---|---|
| Device Name | Examination gloves-Type A(Latex gloves) |
| Applicant | Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. |
| Product Code | LYY · General Hospital |
| Decision Date | Jul 14, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
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.
Device Story
Disposable natural rubber latex examination glove; worn on examiner's hand/finger; acts as physical barrier to prevent contamination between patient and examiner. Used in clinical settings; non-sterile; single-use. Performance verified through barrier testing, physical property assessment, and biocompatibility evaluation. Benefits include protection against cross-contamination during medical examinations.
Clinical Evidence
Bench testing only. No clinical data. Performance verified against ASTM D3578-19 (dimensions, physical properties), ASTM D5151-19 (watertight/holes), ASTM D6124-06 (residual powder), and ASTM D5712-15 (protein content). Biocompatibility testing performed per ISO 10993-10 (sensitization, irritation) and ISO 10993-11 (systemic toxicity). All tests met acceptance criteria.
Technological Characteristics
Material: Natural rubber latex. Form factor: Disposable, non-sterile, powder-free glove. Dimensions: S, M, L sizes. Standards: ASTM D3578-19 (physical properties), ASTM D5151-19 (holes), ASTM D6124-06 (powder), ASTM D5712-15 (protein). Biocompatibility: ISO 10993-10, ISO 10993-11. No software or electronic components.
Indications for Use
Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner.
Regulatory Classification
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.
Predicate Devices
- Powder Free Latex Examination Glove (K173053)
Submission Summary (Full Text)
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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<br>(K214017) | Primary Predicate Device<br>(K173053) | Comparison |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | The Examination gloves-Type A<br>(Latex gloves) is a disposable<br>device intended for medical<br>purposes that is worn on the<br>examiner's hand or finger to<br>prevent contamination between<br>patient and examiner. | A patient examination gloves is a<br>disposable device intended for<br>medical purpose that is worn on<br>the examiner's hand or finger to<br>prevent contamination between<br>patient and examiner | Same |
| Classification<br>Product Code | LYY | LYY | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | Class I | Class I | Same |
| Powdered<br>or | 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.<br>Natural White | | No colour pigment added.<br>Natural White | | Same |
| Dimensions | Length:<br>S: 240-244mm<br>M: 241-245mm<br>L: 242-245mm<br>Width:<br>S: 84-86mm<br>M: 96-98mm<br>L: 105-108mm<br>Palm Thickness: 0.11-0.13mm<br>Finger Thickness: 0.13-014mm | | Length:<br>Average:242mm<br>Width:<br>Average:<br>S:85mm<br>M:95mm<br>L:104mm<br>Palm Thickness: Average:0.09<br>Finger Thickness:Average:0.11 | | Similar<br>Meeting<br>requirement<br>of ASTM<br>D 3578 |
| Biocompatibility | Non-sensitizing<br>Non-irritating<br>Non-systemic toxicity | | Non-sensitizing<br>Non-irritating | | Similar<br>Meeting<br>requirement<br>of ISO 1099 |
| Tensile<br>strength | Before Aging | 20.6MPa, min | Before Aging | 23.65MPa | Similar |
| | Stress at 500 %<br>Elongation | 5.1MPa, max | Stress at 500 %<br>Elongation | 3.5MPa | Meeting<br>requirement<br>of ASTM<br>D 3578 |
| | After Aging | 18.9MPa, min | After Aging | 20.99MPa | |
| Ultimate<br>Elongation | Before Aging | 683%, min | Before Aging | 734% | |
| | After Aging | 623%,min | After Aging | 622% | |
| Freedom from<br>Holes | Meets ASTM D5151-19 | | Meets ASTM D5151-19 | | Same |
| Protein<br>Content | Meets ASTM D5712-2015 | | Meets ASTM D5712-2015 | | Same |
| Powdered<br>residue | Meets ASTM<br>D6124-06(Reapproved 2017) | | Meets ASTM<br>D6124-06(Reapproved 2017) | | Same |
| Sterility | Non-sterile | | Non-sterile | | Same |
| Single Use | YES | | YES | | Same |
| Label and<br>labeling | 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 | ASTM<br>D3578-19 | Length:<br>Min 230 mm for all sizes | Length:<br>S:240-244mm<br>M:241-245mm | Pass |
| | | L:242-245mm | | |
| | ASTM<br>D3578-19 | Width:<br>Small: 80 ± 10 mm<br>Medium: 95±10mm<br>Large: 111± 10 mm | Width:<br>S: 84-86mm<br>M:96-98mm<br>L:105-108mm | Pass |
| | ASTM<br>D3578-19 | Thickness:<br>Palm: 0.08 mm min<br>Finger: 0.08 mm min | Thickness:<br>Palm:0.11-0.13mm<br>Finger: 0.13-014mm | Pass |
| Physical Properties-<br>Tensile strength | ASTM<br>D3578-19 | Before Ageing<br>Tensile Strength: 18Mpa<br>Minimal for all sizes<br>After Ageing Tensile<br>Strength 14Mpa<br>Minimal for all sizes | Before Ageing<br>Tensile Strength:<br>20.6Mpa Min<br>After Ageing<br>Tensile Strength<br>18.9Mpa Min | Pass |
| Physical Properties-<br>Ultimate Elongation | ASTM<br>D3578-19 | Before Ageing<br>Ultimate Elongation:<br>650% Min for all sizes<br>After Ageing<br>Ultimate Elongation<br>500% Min for all sizes | Before Ageing<br>Ultimate Elongation:<br>683% Min<br>After Ageing<br>Ultimate Elongation<br>623% Min | Pass |
| Watertight test | ASTM<br>D5151-19 | Sample size: 200 pcs<br>Inspection level : GI<br>AQL 1.5<br>Acceptance Number 7<br>Rejection Number 8 | Sample size: 200 pcs<br>Inspection level : GI<br>AQL 1.5<br>Result:0 | Pass |
| Residual powder | ASTM<br>D6124-06 | 2 mg per glove or less | 0.02mg per glove | Pass |
| Protein content | ASTM D5712<br>- 15 | 200 µg/dm² Max for all<br>sizes | 75ug/g | Pass |
| Skin Sensitization | ISO 10993-10 | Under the conditions<br>of the study not a<br>sensitizer | Non-sensitizing | Pass |
| Irritation | ISO 10993-10 | Under the condition of<br>study not an irritant | Non-irritating | Pass |
| Systemic toxicity | ISO 10993-<br>11:2017 | Under the conditions of<br>study the device extracts<br>do not pose a systemic<br>toxicity concern | Non-systemic<br>toxicity | 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.
