(87 days)
The powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger or finger to prevent contamination between patient and examiner.
The proposed device is Powder-Free Latex Examination Gloves. The gloves are single use and are provided non-sterile. 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 proposed device is provided with natural color. The device is available in two lengths, each with six sizes, extra-small (XS), small (S), medium (M), large (L) and extra-large (XL), and extra extra-large (XXL). The device is non-sterile.
The provided document is a 510(k) premarket notification for Powder-Free Latex Examination Gloves. This type of device is classified as a Class I medical device (21 CFR 880.6250 - Non-Powdered Patient Examination Glove).
The information requested regarding acceptance criteria and a study proving the device meets those criteria typically applies to more complex devices, especially those involving AI/ML components or requiring clinical performance studies to establish safety and effectiveness.
For this specific device (examination gloves), the "study" that proves it meets acceptance criteria is primarily non-clinical testing against established ASTM and ISO standards for physical properties, integrity, and biocompatibility. Clinical studies are explicitly stated as not included in this submission.
Therefore, many of the requested points are not applicable in the context of this 510(k) submission for examination gloves. I will address the applicable points and explicitly state where information is not present or not relevant to this type of device.
Acceptance Criteria and Device Performance for Powder-Free Latex Examination Gloves (K222612)
For this device, the "acceptance criteria" are defined by compliance with recognized consensus standards (ASTM and ISO). The "study" proving acceptance is the non-clinical testing performed against these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Purpose | Acceptance Criteria (from Standards) | Reported Device Performance (Result) |
|---|---|---|---|
| ASTM D3578-19: Tensile properties (unaged) | Adequate tensile strength | Greater than 18 MPa | Pass |
| Adequate elasticity at 500% elongation | Stress less than 5.5 MPa | Pass | |
| Adequate ultimate elongation | Greater than 650% | Pass | |
| ASTM D3578-19: Tensile properties (after aging) | Adequate tensile strength after aging | Greater than 14 MPa | Pass |
| Adequate ultimate elongation after aging | Greater than 500% | Pass | |
| ASTM D5151-19: Detection of Holes in Medical Gloves | Demonstrate glove integrity | AQL 2.5 | Pass |
| ASTM D6124-06(2017): Residual Powder on Medical Gloves | Demonstrate low powder | Less than 2.0 mg/glove | Pass |
| ASTM D5712-15: Analysis of Aqueous Extractable Protein in Natural Rubber | Demonstrate low level of extractable protein | Not more than 200 µg/dm² | Pass |
| ISO 10993-10:2010: Tests For Irritation And Skin Sensitization | Demonstrate low potential for skin irritation | Not an irritant (under test conditions) | Pass |
| Demonstrate low potential for skin sensitizer | Not a sensitizer (under test conditions) | Pass | |
| ISO 10993-11:2017: Tests for Systemic Toxicity | Demonstrate low acute systemic toxicity | No acute systemic toxicity (under test conditions) | Pass |
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes (e.g., number of gloves) used for each specific non-clinical test. These sample sizes would be specified within the methodologies of the referenced ASTM and ISO standards.
- Data Provenance: The testing was conducted by or on behalf of Guangdong Kingfa Sci.&Tech. Co., Ltd., based in China. The data is from non-clinical laboratory testing, not human subjects, and is inherently retrospective as it was conducted prior to this submission.
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):
- Not applicable. For this type of device, "ground truth" is established by the physical and chemical properties measured against the objective metrics defined in the ASTM and ISO standards, using calibrated equipment and standard laboratory procedures. It does not involve human expert interpretation or consensus comparable to image-based medical device studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for human-interpretable data where multiple readers might have differing opinions (e.g., medical image interpretation). This submission relies on objective laboratory test results.
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. MRMC studies are used for evaluating human performance, typically involving AI assistance in diagnostic tasks. This device is an examination glove, not an AI-enabled diagnostic tool. No clinical study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not have an "algorithm" or standalone AI component. Its performance is measured directly through physical and chemical testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device is based on objective measurements against established engineering and biocompatibility standards. For example, tensile strength measured in MPa, hole detection based on water leak AQL, residual powder in mg/glove, protein content in µg/dm², and ISO 10993 series for biological responses (irritation, sensitization, systemic toxicity) are the "ground truth" metrics.
8. The sample size for the training set:
- Not applicable. This 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:
- Not applicable due to the absence of a training set.
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Guangdong Kingfa Sci.&Tech. Co., Ltd. % Xiaoge Yu Manager Guangdong Kingfa Sci.& Tech.Co., Ltd. No.28, Delong Ave., Shijiao Town, Qingcheng District Qingyuan, Guangdong 511545 China
Re: K222612
Trade/Device Name: Powder-Free Latex Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYY Dated: August 12, 2022 Received: August 30, 2022
Dear Xiaoge Yu:
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.
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
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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 medical devices and radiation-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,
Digitally signed by Ramesh C. Ramesh C. Panquluri -S Panguluri -S Date: 2022.11.25 15:19:07 -05'00' For BiFeng Qian, M,D., Ph.D Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222612
Device Name Powder-Free Latex Examination Gloves
Indications for Use (Describe)
The powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger 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) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | X |
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510(k) Summary K222612
I. Submitter
GUANGDONG KINGFA SCI. & TECH.CO., LTD. No.28, Delong Ave., Shijiao Town, Qingcheng District, Qingyuan, Guangdong, China Contact person: Xiaoge Yu Position: Manager Tel.: +86-13570952157 E-mail: yuxiaoge@kingfa.com.cn Preparation date: November 21, 2022
II. Proposed Device
| Device Trade Name | Powder-Free Latex Examination Gloves |
|---|---|
| Common name: | Latex Patient Examination Gloves |
| Regulation Number: | 21 CFR 880.6250 |
| Regulatory Class: | Class I |
| Product code: | LYY |
| Review Panel | General Hospital |
III. Predicate Devices
| 510(k) Number: | K214017 |
|---|---|
| Trade name: | Examination gloves-Type A (Latex gloves) |
| Common name: | Latex Patient Examination Gloves |
| Classification: | Class I |
| Product Code: | LYY |
| Manufacturer: | Jiangxi Kemei Medical Apparatus & Instruments GroupCo., Ltd |
IV. Device description
The proposed device is Powder-Free Latex Examination Gloves. The gloves are single use and are provided non-sterile. 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 proposed device is provided with natural color. The device is available in two lengths, each with six sizes, extra-small (XS), small (S), medium (M), large (L) and extra-large (XL), and extra extra-large (XXL). The device is non-sterile.
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V. Indication for use
The powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger or finger to prevent contamination between patient and examiner.
VI. Comparison of technological characteristics with the predicate devices
| Item | Proposed device | Predicate device(K214017) | Discussion |
|---|---|---|---|
| Product name | Powder-Free Latex Examination Gloves | Examination gloves-Type A(Latex gloves) | - |
| Product Code | LYY | LYY | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Classification | Class I | Class I | Same |
| Powder free | Yes | Yes | Same |
| Indication for use | The powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger or finger to prevent contamination between patient and examiner. | 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. | Similar |
| Main Material | Natural rubber latex | Natural rubber latex | Same |
| Color | Natural color | Natural White color | Similar |
| Size | X-Small, Small, Medium, Large, X-large, XX-large, | Small, Medium, Large | Similar |
| Palm width | X- Small(70±10mm)Small (80±10mm)Medium (95±10mm)Large (110±10mm)X-large (120±10mm) | Small (84-86mm)Medium (96-98mm)Large (105-108mm) | Similar |
| XX-large (130±10mm) | |||
| Length | Short styleXS(220mm min)S (220mm min)M (230mm min)L (230mm min)XL (230mm min)XXL (230mm min)Long styleXS~XXL(280mm min) | ≥230mm | Similar |
| Thickness | Palm: 0.05mm minFinger: 0.08mm min | Palm: 0.11-0.13mmFinger:0.13-0.14mm | Similar |
| Freedom fromholes | Meets requirementsof ASTM D3578-19 | Meets requirementsof the ASTM D3578-19 | Same |
| PhysicalProperties(before aging) | Meets requirementsof ASTM D3578-19 | Meets requirementsof ASTM D3578-19 | Same |
| PhysicalProperties(after aging) | Meets requirementsof ASTM D3578-19 | Meets requirementsof ASTM D3578-19 | Same |
| Powderresidue | Meets requirementsof ASTM D3578-19 | Meets requirementsof ASTM D3578-19 | Same |
| Protein Content | Meets requirementsof ASTM D3578-19 | Meets requirementsof ASTM D3578-19 | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Shelf Life | - | 5 Years | Different |
| For single use | Yes | Yes | Same |
| Type of use | Over the counter use | Over the counter use | Same |
| Biocompatibility | Confirm to therequirements of ISO10993 seriesstandards | Confirm to therequirements of ISO10993 seriesstandards | Same |
Table 1 Comparison of Latex examination gloves
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As above comparison, the differences in the dimensions of the subject and predicate device do not affect the safety and effectiveness of the device for its intended use. The biocompatibility test and performance test of the subject devices have been performed on the final finished device.
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VII. Non-Clinical Testing
Non clinical tests were conducted in accordance with following standards to verify that the subject device (short and long variants) met all design specifications.
| Test | Purpose | Criteria | Result | |
|---|---|---|---|---|
| ASTM D3578-19Tensile properties | Demonstrateadequate tensilestrength (unaged) | Greater than 18 MPa | Pass | |
| Demonstrateadequate elasticityat 500% elongation(unaged) | Stress less than 5.5 MPa | Pass | ||
| Demonstrateadequate ultimateelongation(unaged) | Greater than 650% | Pass | ||
| Demonstrateadequate tensilestrength after aging | Greater than 14 MPa | Pass | ||
| Demonstrateadequate ultimateelongation afteraging | Greater than 500% | Pass | ||
| ASTM D5151-19Standard TestMethod forDetection of Holesin Medical Gloves | Demonstrate gloveintegrity | AQL 2.5 | Pass | |
| ASTM D6124-06(2017), StandardTest Method forResidual Powder onMedical Gloves | Demonstrate lowpowder | Less than 2.0 mg/glove | Pass | |
| ASTM D5712-15,Standard TestMethod for Analysisof AqueousExtractable Proteinin Natural Rubber | Demonstrate lowlevel of extractableprotein | protein content not morethan 200 µg/ dm² | Pass | |
| in Latex, NaturalRubber, andElastomericProducts Using theModified LowryMethod | ||||
| ISO 10993-10:2010 BiologicalEvaluation OfMedical Devices -Part 10: Tests ForIrritation And SkinSensitization. | Demonstrate lowpotential for skinirritation | Under the conditions of thetesting, not an irritant | Pass | |
| Demonstrate lowpotential for skinsensitizer | Under the conditions of thetesting, not a sensitizer | Pass | ||
| ISO 10993-11:2017, Biologicalevaluation ofmedical devices –Part 11:Tests forSystemic Toxicity | Demonstrate lowacute systemictoxicity | Under the conditions of the testing, noacute systemic toxicity | Pass |
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VIII. Clinical Testing
No clinical study is included in this submission.
IX. Conclusion
The conclusions drawn from the non-clinical testing demonstrate that the Powder-Free Latex Examination Gloves are as safe, as effective, and perform as well as or better than the predicate Examination gloves-Type A (Latex gloves) (K214017).
§ 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.