(295 days)
The biodegradable nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The propose devices is powder free nitrile patient examination gloves, provided as non-sterile and disposable device. The gloves are offered in six sizes, extra-small (6.5"), small (7"), medium (8"), large (8.5"), extra-large (9"), extra extra-large (9.5"). Three colors are available for all size, includes blue, blue violet and green.
This document, K221983, is a 510(k) Premarket Notification for Biodegradable Powder Free Nitrile Examination Gloves. The device in question is a Class I medical device, meaning it is subject to general controls and typically does not require extensive clinical studies for clearance if substantial equivalence to a predicate device can be demonstrated.
Based on the provided text, the "device" is a Nitrile Examination Glove, not an advanced AI or diagnostic device that would involve AI-assisted reading or complex image analysis. Therefore, the questions related to AI (e.g., effect size of human readers improving with AI, standalone algorithm performance, training set size, adjudication methods, number of experts for ground truth) are not applicable to this type of medical device submission.
The "study" referenced in this document is a series of non-clinical, in-vitro laboratory tests performed to demonstrate that the glove meets established industry standards and specifications, proving its safety and performance equivalence to a legally marketed predicate device.
Here's the information extracted from the document relevant to your request, but tailored to the nature of this Class I device:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length:Extra-Small: ≥ 220mmSmall: ≥ 220mmMedium: ≥ 230mmLarge: ≥ 230mmExtra-Large: ≥ 230mmExtra-Extra-Large: ≥ 230mmWidth:Extra-Small: 70 ± 10 mmSmall: 80 ± 10mmMedium: 95 ± 10mmLarge: 110 ± 10mmExtra-Large: 120 ± 10mmExtra-Extra-Large: ≥120mm | Pass |
| ASTM D6319 | Physical properties (Thickness) | Thickness (mm):Finger: ≥0.05Palm: ≥0.08 | Pass |
| ASTM D6319 | Physical properties (Before Aging) | Tensile Strength: ≥14MPaUltimate Elongation: ≥500% | Pass |
| ASTM D6319 | Physical properties (After Aging) | Tensile Strength: ≥14MPaUltimate Elongation: ≥500% | Pass |
| ASTM D5151 | Freedom from pinholes | Meet the requirements of ASTM D5151 Test for AQL 2.5 | Pass |
| ASTM D6124 | Powder Residue | Meet the requirements of ASTM D6124 < 2.0mg | Pass |
| ISO 10993-10 | To determine if the finished device material is an irritant | Non-irritating | Non-irritant / Pass |
| ISO 10993-10 | To determine if the finished device material is a sensitizer | Non-sensitizing | Non-sensitizer / Pass |
| ISO 10993-11 | To determine if the finished device material extracts pose a systemic toxicity concern | Non-acute systemic toxicity | Non-acute systemic toxicity in vivo / Pass |
2. Sample sized used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for pinholes or dimensions). However, the tests are in accordance with the specified ASTM and ISO standards, which typically define appropriate sample sizes for such tests.
Data provenance: The testing was conducted by Guangdong Kingfa Sci. & Tech. Co., LTD., based in China. The data likely comes from laboratory testing conducted directly by or for the manufacturer. The data is retrospective in the sense that it was collected prior to the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the device. Ground truth for glove testing is established through physical measurements, chemical analysis, and standardized biological tests conducted in laboratories, not by expert consensus of human readers. The "experts" would be the certified laboratory technicians and scientists performing the tests according to the standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective interpretations, especially in clinical image reading. The testing for gloves involves objective measurements and standardized protocols.
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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this device is based on objective, standardized measurements and laboratory test results defined by internationally recognized standards (ASTM, ISO). For example, a glove has a physical dimension (e.g., length, width), a certain tensile strength, or a specific level of powder residue, as measured by precise instruments and chemical analyses. Biocompatibility (irritation, sensitization, systemic toxicity) is determined by in-vivo/in-vitro assays according to ISO standards.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
April 27, 2023
Guangdong Kingfa Sci. & Tech. Co., LTD. Xiaoge Yu Manager No.28, Delong Ave., Shijiao Town, Qingcheng District Qingyuan, Guangdong 511545 China
Re: K221983
Trade/Device Name: Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: November 8, 2022 Received: April 24, 2023
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.
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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 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.
Bifeng Qian -S
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) K221983
Device Name
Biodegradable Powder Free Nitrile Examination Glove, Blue Color Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color Biodegradable Powder Free Nitrile Examination Glove, Green Color
Indications for Use (Describe)
The biodegradable nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
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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K221983-510(k) Summary
I. Submitter
GUANGDONG KINGFA SCI. & TECH.CO., LTD. No. 28 Delong Avenue, Shijiao Town, Qingcheng District, Qingyuan City, Guangdong Province 511545, China
Contact person: Xiaoge Yu Position: Manager Tel.: +86-13570952157 E-mail: yuxiaoge@kingfa.com.cn
Revision date: September 7, 2022
II. Proposed Device
| Device Trade Name | Biodegradable Powder Free Nitrile Examination Glove, Blue Color |
|---|---|
| Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color | |
| Biodegradable Powder Free Nitrile Examination Glove, Green Color | |
| Common name: | Polymer Patient Examination Glove |
| Regulation Number: | 21 CFR 880.6250 |
| Regulatory Class: | Class I |
| Product code: | LZA |
| Review Panel | General Hospital |
III. Predicate Device
| 510(k) Number: | K162312 |
|---|---|
| Trade name: | Biodegradable Powder Free Nitrile Exam Gloves With Aloe Vera,Green Color |
| Common name: | Patient Examination Gloves |
| Classification: | Class I |
| Product Code: | LZA |
| Manufacturer | Shen Wei USA Inc. |
IV. Device description
The propose devices is powder free nitrile patient examination gloves, provided as
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non-sterile and disposable device. The gloves are offered in six sizes, extra-small (6.5"), small (7"), medium (8"), large (8.5"), extra-large (9"), extra extra-large (9.5"). Three colors are available for all size, includes blue, blue violet and green.
V. Indication for use
The biodegradable nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
VI. Comparison of technological characteristics with the predicate devices
| Item | Proposed device(K221983) | Predicatedevice(K162312) | Discussion |
|---|---|---|---|
| Product name | BiodegradablePowder Free NitrileExamination Glove,Blue ColorBiodegradablePowder Free NitrileExamination Glove,Blue Violet ColorBiodegradablePowder Free NitrileExamination Glove,Green Color | BiodegradablePowder FreeNitrile ExamGloves With AloeVera,Green Color | - |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Classification | Class I | Class I | Same |
| Powder free | Yes | Yes | Same |
| Indication foruse | The biodegradablenitrile examinationglove is intended to beworn on the hands ofexaminer's to preventcontamination betweenpatient and examiner.This is a single-use. | The biodegradablepowder free nitrileexam gloves withaloe vera, greencolor is adisposable deviceintendedfor medical | Same |
| powder-free, non-sterile device. | purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only. | ||
| Main Material | Nitrile rubber | Nitrile rubber | Same |
| Color | Blue\Blue violet\Green | Green | Similar |
| Size | X-Small (6.5), Small(7), Medium (8), Large(8.5),X-large(9), XX-large(9.5), | Ambidextrous in different sizes per ASTM D6319-10 Dimensions requirement | SimilarOnly the different standard version. This requirement given in the standard is the same. |
| Palm width | X- Small (70±10mm)Small (80±10mm)Medium(95±10mm)Large(110±10mm)X-large(120±10mm)XX-large( $\ge$ 120mm) | Ambidextrous in different sizes per ASTM D6319-10 dimensions requirement | SimilarOnly the different standard version. This requirement given in the standard is the same. |
| Length | XS(220mm min)S (220mm min)M (230mm min)L (230mm min)XL (230mm min)XXL (230mm min) | Ambidextrous in different sizes per ASTM D6319-10 Dimensions requirement | SimilarOnly the different standard version. This requirement given in the standard is the same. |
| Palm: 0.05mm min | Ambidextrous in | Similar | |
| Thickness | Finger: 0.08mm min | different sizes perASTM D6319-10dimensionsrequirement | Only the differentstandard version.This requirementgiven in thestandard is thesame. |
| Freedom fromholes | Meets requirements ofthe ASTM D6319-19 | Meetsrequirements ofthe ASTM D6319-10 | SimilarOnly the differentstandard version.This requirementgiven in thestandard is thesame. |
| PhysicalProperties(before aging) | Meets requirements ofthe ASTM D6319-19 | Meetsrequirements ofthe ASTM D6319-10 | SimilarOnly the differentstandard version.Therequirements ofphysicalproperties givenin the standardare the same. |
| PhysicalProperties (afteraging) | Meets requirements ofthe ASTM D6319-19 | Meetsrequirements ofthe ASTM D6319-10 | SimilarOnly thedifferentstandardversion. Therequirements ofphysicalproperties givenin the standardare the same. |
| Powderresidual | ≤2.0 mg/gloves | ≤2.0 mg/gloves | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| BiodegradationProperties | Biodegradable | Biodegradable | Same |
| For single use | Yes | Yes | Same |
| Type of use | Over the counter use | Over thecounter use | Same |
| Biocompatibility | Skin Sensitization-ISO 10993-10Irritation-ISO 10993-10 | Skin Sensitization-ISO10993-10Irritation-ISO 10993-10 | Similar |
| Acute Systemic Toxicity-ISO 10993-11 |
Table 1 Comparison of Nitrile Examination Gloves
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As above comparison, the difference in the reference standard version of the subject and predicate device does not raise additional questions for safety and effectiveness of the device. The biocompatibility test and performance test of the subject devices have been performed on the final finished device. The test results shows the predicate device meet the specifications of ASTM D 6319. So we consider this as the proposed device is similar to the predicate device.
VII. Non-Clinical Testing
Non clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications.
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for . Medical Application
- ASTM D3767-03(2020), Practice for rubber-Measurement of Dimensions ●
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves ●
- ASTM D6124-06(2017), Standard Test Method for Residual Powder on Medical ● Gloves
- ASTM D573-04(2019), Standard Test Method for Rubber—Deterioration in an Air Oven
- ASTM D412-16, Standard Test Methods for Vulcanized Rubber and . Thermoplastic Elastomers-Tension
- 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 Part11:Tests for . Systemic Toxicity
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319 | PhysicalDimensions Test | Extra-Small:Length: $\ge$ 220mm Width: 70 $\pm$ 10 mm;Small:Length: $\ge$ 220mm Width: 80 $\pm$ 10mm;Medium:Length: $\ge$ 230mm Width: 95 $\pm$ 10mmLarge:Length: $\ge$ 230mm Width: 110 $\pm$ 10mmExtra- Large:Length: $\ge$ 230mm Width: 120 $\pm$ 10mmExtra- Extra- Large: | Pass |
Table 2 Summary of Non-Clinical Performance Testing
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| Physicalproperties | Length: ≥ 230mm Width: ≥120mm | Pass | |||
|---|---|---|---|---|---|
| Thickness (mm): | |||||
| Finger:≥0.05 | |||||
| Palm: ≥0.08 | |||||
| BeforeAging | TensileStrength | ≥14MPa | |||
| UltimateElongation | ≥500% | ||||
| After Aging | TensileStrength | ≥14MPa | Pass | ||
| UltimateElongation | ≥500% | ||||
| ASTM D5151 | Freedom frompinholes | Meet the requirements of ASTMD5151 Test for AQL 2.5 | Pass | ||
| ASTM D6124 | Powder Residue | Meet the requirements of ASTMD6124< 2.0mg | Pass | ||
| ISO 10993-10 | To determine ifthe finished devicematerial is an irritant | Non-irritating | Under theconditions of thestudy not anirritant/ Pass | ||
| ISO 10993-10 | To determine ifthe finished devicematerial is asensitizer | Non- sensitizing | Under conditionsof the study, not asensitizer. / Pass | ||
| ISO 10993-11 | To determine ifthe finished devicematerial extractspose a systemictoxicity concern | Non-acute systemic toxicity | Under conditionsof the study, didnot show acutesystemic toxicityin vivo / Pass |
VIII. Clinical Testing
No clinical study is included in this submission.
IX. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K221983, Biodegradable Powder Free Nitrile Examination Gloves, is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Shen Wei Biodegradable Powder Free Nitrile Examination Gloves, cleared under 510(k) K162312.
§ 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.