(87 days)
The 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 proposed devices are provided with white, black and pink color. There are six sizes, extra-small, medium, large and extra-large, extra extra-large for optional.
This is a 510(k) summary for a medical device (Nitrile Examination Gloves), not for an AI/ML powered device, therefore, the requested information elements related to AI/ML device studies (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, and ground truth establishment for training set) are not applicable.
The document describes non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
Here's the table of acceptance criteria and reported device performance based on the provided document:
Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| ASTM D6319 - Physical Dimensions Test | ||||
| Length (XS) | $\ge$ 220 mm | 226 mm | Pass | |
| Width (XS) | 70 $\pm$ 10 mm | 73 mm | Pass | |
| Length (S) | $\ge$ 220 mm | 225 mm | Pass | |
| Width (S) | 80 $\pm$ 10 mm | 85 mm | Pass | |
| Length (M) | $\ge$ 230 mm | 235 mm | Pass | |
| Width (M) | 95 $\pm$ 10 mm | 98 mm | Pass | |
| Length (L) | $\ge$ 230 mm | 234 mm | Pass | |
| Width (L) | 110 $\pm$ 10 mm | 115 mm | Pass | |
| Length (XL) | $\ge$ 230 mm | 235 mm | Pass | |
| Width (XL) | 120 $\pm$ 10 mm | 123 mm | Pass | |
| Length (XXL) | $\ge$ 230 mm | 235 mm | Pass | |
| Width (XXL) | $\ge$ 120 mm | 124 mm | Pass | |
| Thickness | ||||
| Finger Thickness | $\ge$ 0.08 mm | X-Small: 0.104 mm; Small: 0.106 mm; Medium: 0.104 mm; Large: 0.105 mm; X-Large: 0.106 mm; XX-Large: 0.105 mm | Pass | |
| Palm Thickness | $\ge$ 0.05 mm | X-Small: 0.059 mm; Small: 0.060 mm; Medium: 0.060 mm; Large: 0.062 mm; X-Large: 0.061 mm; XX-Large: 0.058 mm | Pass | |
| Physical Properties (Before Aging) | ||||
| Tensile Strength | $\ge$ 14 MPa | Lot1: 17.6 MPa; Lot2: 18.5 MPa; Lot3: 18.2 MPa | Pass | |
| Ultimate Elongation | $\ge$ 500% | Lot1: 552%; Lot2: 573%; Lot3: 583% | Pass | |
| Physical Properties (After Aging) | ||||
| Tensile Strength | $\ge$ 14 MPa | Lot1: 19.8 MPa; Lot2: 20.3 MPa; Lot3: 20.1 MPa | Pass | |
| Ultimate Elongation | $\ge$ 500% | Lot1: 521%; Lot2: 518%; Lot3: 526% | Pass | |
| ASTM D5151 - Freedom from Pinholes | Freedom from pinholes | Meet the requirements of ASTM D5151 Test for AQL 2.5 | Lot1: $\le$ AQL 2.5; Lot2: $\le$ AQL 2.5; Lot3: $\le$ AQL 2.5 | Pass |
| ASTM D6124 - Powder Residue | Powder Residue | $\le$ 2.0 mg | Lot1: 1.2 mg; Lot2: 1.5 mg; Lot3: 1.2 mg | Pass |
| ISO 10993-10 - Irritation | To determine if the finished device material is an irritant | Non-irritating | Under the conditions of the study, not an irritant | Pass |
| ISO 10993-10 - Sensitization | To determine if the finished device material is a sensitizer | Non-sensitizing | Under conditions of the study, not a sensitizer | Pass |
| ISO 10993-11 - Systemic Toxicity | To determine if the finished device material extracts pose a systemic toxicity concern | Non-acute systemic toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo | Pass |
Study Details
- Sample size used for the test set and the data provenance: Not applicable. These are non-clinical bench tests on physical products, not an AI/ML test set. The tests were performed on "Lots" of the gloves (Lot1, Lot2, Lot3). The specific sample size for each test within these lots is not specified in this document but implied to be sufficient for meeting the ASTM/ISO standards. The data provenance is from non-clinical testing of the manufacturing output.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as these are objective physical and chemical tests, not requiring expert ground truth in the context of AI/ML evaluation.
- Adjudication method for the test set: Not applicable. The results are based on objective measurements against defined standards.
- 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 concerns a physical medical device (gloves), not an AI/ML powered device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This concerns a physical medical device (gloves), not an AI/ML powered device.
- The type of ground truth used: For physical/chemical properties (e.g., length, thickness, tensile strength, freedom from pinholes, powder residue), the "ground truth" is the quantitative measurement obtained through standardized test methods (ASTM and ISO standards) and compared against pre-defined numerical or qualitative acceptance criteria. For biocompatibility tests (irritation, sensitization, systemic toxicity), the ground truth is established by the outcome of the biological assays as per ISO 10993 standards.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
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September 24, 2022
Guangdong Kingfa Sci. & Tech. Co., Ltd. Xiaoge Yu Manager No. 28 Delong Ave., Shijiao Town, Qingcheng District Qingyuan, Guangdong 511545 China
Re: K221887
Trade/Device Name: Nitrile Examination Glove, Pink Color, Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, Dated: June 9, 2022 Received: June 29, 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.
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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 Oian, 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221887
Device Name
Nitrile Examination Glove, Pink Color Nitrile Examination Glove, Black Color Nitrile Examination Glove, White Color
Indications for Use (Describe)
The 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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K221887-510(k) summary
l. 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
Preparation date: June 09, 2022
II. Proposed Device
| Device Trade Name | Nitrile Examination Glove, Pink Color |
|---|---|
| Nitrile Examination Glove, Black Color | |
| Nitrile Examination Glove, White 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 Devices
| 510(k) Number: | K190942 |
|---|---|
| Trade name: | Disposable Powder Free Nitrile Examination Glove, Pink/BlackColor |
| Common name: | Patient Examination Gloves |
| Classification: | Class I |
| Product Code: | LZA |
| Manufacturer | Ever Growth (Vietnam) Co. Ltd. |
IV. Device description
The propose devices is powder free nitrile patient examination gloves, provided as non-sterile and disposable device. The proposed devices are provided with white, black and pink color. There are six sizes, extra-small, medium, large and extra-large, extra extra-large for optional.
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V. Indication for use
The 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 | Predicate device(K190942) | Discussion |
|---|---|---|---|
| Product name | Nitrile ExaminationGlove, Pink ColorNitrile ExaminationGlove, Black ColorNitrile ExaminationGlove, White Color | Disposable PowderFree NitrileExamination Glove,Pink/Black 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 nitrileexamination glove isintended to be wornon the hands ofexaminer's to preventcontaminationbetween patient andexaminer. This is asingle-use,powder-free,non-sterile device. | The Nitrile PowderFree patientexamination glove isa non-steriledisposable deviceintended for medicalpurposes that is wornon the examiner'shands or finger topreventcontaminationbetween patient andexaminer. | Same |
| Main Material | Nitrile rubber | Nitrile rubber | Same |
| Color | Pink\ Black\ White | Pink\ Black | Similar |
| Size | X-Small, Small,Medium, Large,X-large. XX-large. | X-Small, Small,Medium, Large,X-large | Similar |
| Palm width | X- Small(70±10mm) | X- Small(70±10mm) | Similar |
| Small (80±10mm) | Small (80±10mm) | ||
| Medium (95±10mm) | Medium (95±10mm) | ||
| Large (110±10mm) | Large (110±10mm) | ||
| X-large (120±10mm) | X large (120±10mm) | ||
| XX-large (≥ 120mm) | |||
| Length | XS(220mm min) | ≥230mm | Similar |
| S (220mm min) | |||
| M (230mm min) | |||
| L (230mm min) | |||
| XL (230mm min) | |||
| XXL (230mm min) | |||
| Palm: 0.05mm min | Palm≥0.05mm | Similar | |
| Thickness | Finger: 0.08mm min | Finger tip≥0.05mm | |
| Freedom from | Meets requirements | Meets requirements | Similar |
| holes | of the ASTM | of the ASTM | |
| D6319-19 | D6319-10 | ||
| Physical | Meets requirements | Meets requirements | Similar |
| Properties | of the ASTM | of the ASTM | |
| (before aging) | D6319-19 | D6319-10 | |
| Physical | Meets requirements | Meets requirements | Similar |
| Properties | of the ASTM | of the ASTM | |
| (after aging) | D6319-19 | D6319-10 | |
| Powder | ≤2.0 mg/gloves | ≤2.0 mg/gloves | Same |
| residual | |||
| Sterility | Non-sterile | Non-sterile | Same |
| For single use | Yes | Yes | Same |
| Type of use | Over the counter use | Over the counter use | Same |
| Biocompatibility | ISO 10993-10 | ISO 10993-10 | Same |
| Under the conditions | Under the conditions | ||
| of the study, not an | of the study, not an | ||
| irritant and sensitizer | irritant and sensitizer | ||
| ISO 10993-11 | |||
| Cytotoxicity is | |||
| assessed via | |||
| rationale. Under the | |||
| condition of acute | |||
| systemic toxicity test, | |||
| the test article did not | |||
| show acute systemictoxicity in vivo. |
Table 1 Comparison of Nitrile Examination Gloves
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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: $\geq$ 220mm Width: 70 $\pm$ 10 mm; | Pass |
| Small:Length: $\geq$ 220mm Width: 80 $\pm$ 10mm; | X-Small:Length: 226 mmWidth: 73 mm; | ||
| Medium:Length: $\geq$ 230mm Width: 95 $\pm$ 10mm | Small:Length: 225 mmWidth: 85 mm; | ||
| Large:Length: $\geq$ 230mm Width: 110 $\pm$ 10mm | Medium:Length: 235 mmWidth: 98 mm; | ||
| Extra- Large:Length: $\geq$ 230mm Width: 120 $\pm$ 10mm | Large:Length: 234 mm | ||
| Extra- Extra- Large:Length: $\geq$ 230mm Width: $\geq$ 120mm |
| Table 2 Summary of Non-Clinical Performance Testing |
|---|
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| Width: 115 mm; | |||||
|---|---|---|---|---|---|
| X- Large: | |||||
| Length: 235 mm | |||||
| Width: 123 mm; | |||||
| XX-Large: | |||||
| Length: 235 mm | |||||
| Width: 124 mm; | |||||
| Thickness (mm): | Pass | ||||
| Finger:≥0.08Palm: ≥0.05 | X-Small: | ||||
| Finger: 0.104 mm | |||||
| Palm: 0.059 mm; | |||||
| Small: | |||||
| Finger: 0.106 mm | |||||
| Palm: 0.060 mm; | |||||
| Medium: | |||||
| Finger: 0.104 mm | |||||
| Palm: 0.060 mm; | |||||
| Large: | |||||
| Finger: 0.105 mm | |||||
| Palm: 0.062 mm; | |||||
| X- Large: | |||||
| Finger: 0.106 mm | |||||
| Palm: 0.061mm; | |||||
| XX-Large: | |||||
| Finger: 0.105 mm | |||||
| Palm: 0.058 mm; | |||||
| Physicalproperties | BeforeAging | TensileStrength | ≥14MPa | Pass | |
| Lot1:17.6MPa, 552% | |||||
| UltimateElongation | ≥500% | Lot2:18.5MPa, 573% | |||
| Lot3:18.2MPa, 583% | |||||
| After Aging | TensileStrength | ≥14MPa | Pass | ||
| UltimateElongation | ≥500% | Lot1:19.8MPa, 521%Lot2:20.3MPa, 518%Lot3:20.1MPa, 526% | |||
| ASTM D5151 | Freedom frompinholes | Meet the requirements of ASTM D5151Test for AQL 2.5 | PassLot1: ≤ AQL 2.5Lot2: ≤ AQL 2.5Lot3: ≤ AQL 2.5 | ||
| ASTM D6124 | Powder Residue | Meet the requirements of ASTM D6124< 2.0mg | PassLot1: 1.2 mgLot2: 1.5 mgLot3: 1.2 mg | ||
| ISO 10993-10 | To determine if thefinished devicematerial is anirritant | Non-irritating | Under theconditions of thestudy not anirritant/ Pass | ||
| ISO 10993-10 | To determine if thefinished devicematerial is asensitizer | Non- sensitizing | Under conditionsof the study, not asensitizer. / Pass | ||
| ISO 10993-11 | To determine if thefinished devicematerial extractspose a systemictoxicity concern | Non-acute systemic toxicity | Under conditionsof the study, didnot show acutesystemic toxicityin vivo / Pass |
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VIII. Clinical Testing
No clinical study is included in this submission.
IX. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed 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.