(205 days)
Nitrile Examination Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Examination Gloves are made of Nitrile rubber and are blue in color. The device is powder free nitrile examination gloves. It can be available in five specifications: XS, S, M, L and XL. The subject device is non-sterile.
The provided text is for a 510(k) premarket notification for Nitrile Examination Gloves, a Class I medical device. This type of device is a physical product, not an AI/ML algorithm or software. Therefore, the "acceptance criteria and the study that proves the device meets the acceptance criteria" requested in the prompt refers to physical and biological performance testing for the gloves, not to a study about the performance of an AI model.
Here's the breakdown of the information based on the provided text, adapted for a physical device:
Acceptance Criteria and Device Performance for Nitrile Examination Gloves
The study to prove the device meets acceptance criteria involved non-clinical tests based on recognized standards for medical gloves.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Extra-Small: Length: ≥220mm; Width: 70±10 mm Small: Length: ≥220mm; Width: 80±10mm Medium: Length: ≥230mm; Width: 95±10mm Large: Length: ≥230mm; Width: 110±10mm Extra-Large: Length: ≥230mm; Width: 120±10mm | Pass |
| Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Pass | ||
| ASTM D6319 | Physical Properties (Before Aging) | Tensile Strength: ≥14MPa Ultimate Elongation: ≥500% | Pass |
| Physical Properties (After Aging) | Tensile Strength: ≥14MPa Ultimate Elongation: ≥500% | Pass | |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 Test for AQL 2.5 | Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 <2.0mg | Pass |
| ISO 10993-11 | Systemic Toxicity | Non-acute systemic toxicity | Pass |
| ISO 10993-10 | Irritation (Biocompatibility) | Non-irritating | Pass |
| ISO 10993-10 | Sensitization (Biocompatibility) | Non-sensitizing | Pass |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes used for each test (e.g., number of gloves tested for dimensions, holes, etc.) or the provenance of the materials/specimens (e.g., country of origin, retrospective or prospective). It indicates that "Non-clinical tests were conducted to verify that the proposed device met all design specifications."
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 as the "ground truth" for a physical device like medical gloves is established through direct physical, chemical, and biological testing according to predefined standards and objective measurements, not by expert consensus on interpretations. The tests are performed by trained personnel in laboratories.
4. Adjudication method for the test set
Not applicable. The tests involve objective measurements against pass/fail criteria from recognized standards, not expert adjudication of subjective assessments.
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 a physical medical device (nitrile examination gloves), not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an AI/ML algorithm.
7. The type of ground truth used
The ground truth is established by objective measurements and observations in accordance with standardized test methods (ASTM and ISO standards). For example:
- Physical Dimensions: Measured length and width of gloves.
- Thickness: Measured thickness at finger and palm.
- Physical Properties (Tensile Strength, Elongation): Mechanically tested to quantify material strength and stretch.
- Watertightness: Direct testing for leaks/holes.
- Powder Content: Quantified residue weight.
- Biocompatibility (Systemic Toxicity, Irritation, Sensitization): In vivo animal testing or in vitro assays as defined by ISO 10993 standards to observe biological reactions.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The manufacturing process is validated, not trained.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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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 and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
June 22, 2022
Hangzhou Runheng Medical Co., Ltd. Yaya Lu QC Manager Room 201, Shunfeng Building, NO.109 Hongxing Road, Qiaonan Block Hangzhou, Zhejiang 311215 China
Re: K213739
Trade/Device Name: Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: May 10, 2022 Received: May 25, 2022
Dear Yaya Lu:
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213739
Device Name Nitrile Examination Gloves
Indications for Use (Describe)
Nitrile Examination Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand 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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K213739-510(k) summary
I Submitter
| Device submitter: | Hangzhou Runheng Medical Co., Ltd. |
|---|---|
| Room 201, Shunfeng Building, NO.109 Hongxing Road, Qiaonan | |
| Block, Xiaoshan Economic and Technological Development Zone, | |
| Hangzhou, Zhejiang Province, P.R.China. |
| Contact person: | Yaya Lu |
|---|---|
| QC Manager | |
| Phone: +86 18285158974 | |
| E-mail: 1264726347@qq.com |
Date of Preparation: May 16th, 2022
II Proposed Device
| 510(k) Number: | K213739 |
|---|---|
| Trade/Device Name: | Nitrile Examination Gloves |
| Regulation Number: | 21 CFR 880.6250 |
| Regulation Name: | Non-powdered patient examination glove |
| Regulatory Class: | Class I |
| Product code: | LZA |
| Review Panel: | General Hospital |
III Predicate Devices
| 510(k) Number: | K211515 |
|---|---|
| Trade/Device Name: | Nitrile Examination Gloves |
| Regulation Number: | 21 CFR 880.6250 |
| Regulation Name: | Non-powdered patient examination glove |
| Classification: | Class I |
| Product Code: | LZA |
| Manufacturer | Beijing Reagent Latex Products Co., Ltd. |
IV Device description
Nitrile Examination Gloves are made of Nitrile rubber and are blue in color. The device is powder free nitrile examination gloves. It can be available in five specifications: XS, S, M, L and XL.
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The subject device is non-sterile.
V Indication for use
Nitrile Examination Gloves are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
VI Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate devices. The test results demonstrated that the proposed device complies with the following standards:
- A ASTM D5151 Standard Test Method for Detection of Holes in Medical Gloves
- A ASTM D6124 Standard Test Method for Residual Powder on Medical Gloves
- ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical > Application
-
ISO 10993-10: 2010 Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization
- A ISO 10993-11: 2017 Biological evaluation of medical devices-Part 11: Tests for systemic toxicity
| TestMethod | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTMD6319 | PhysicalDimensions Test | Extra-Small:Length: ≥220mm; Width: 70±10 mmSmall:Length: ≥ 220mm; Width: 80±10mmMedium:Length: ≥ 230mm; Width: 95±10mmLarge:Length: ≥230mm; Width: 110±10mmExtra- Large:Length: ≥230mm; Width: 120±10mm | Pass |
| Thickness (mm):Finger:≥0.05Palm: ≥0.05 | Pass | ||
| ASTMD6319 | Physicalproperties | BeforeAging Tensile Strength | ≥14MPa |
| BeforeAging Ultimate Elongation | ≥500% | ||
| AfterAging Tensile Strength | ≥14MPa | ||
| AfterAging Ultimate Elongation | ≥500% | ||
| ASTMD5151 | WatertightnessTest for Detectionof Holes | Meet the requirements of ASTMD5151Test for AQL 2.5 | Pass |
Table 1 Summary of Non-Clinical Performance Testing
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| ASTMD6124 | Powder Content | Meet the requirements of ASTMD6124<2.0mg | Pass |
|---|---|---|---|
| ISO10993-11 | 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 |
| ISO10993-10 | To determine if the finished device material is an irritant. | Non-irritating | Under the conditions of the study not an irritant/ Pass |
| ISO10993-10 | To determine if the finished device material is a sensitizer. | Non-sensitizing | Under conditions of the study, not a sensitizer. / Pass |
VII Clinical Test Conclusion
No clinical study is included in this submission.
VIII Summary of Technological characteristics
Table 2 Technological Characteristics Comparison Table
| Item | Subject device | Predicate device | Discussion |
|---|---|---|---|
| Product name | Nitrile Examination Gloves | Snow Lotus NitrileExamination Gloves | NA |
| 510(k) Number | K213739 | K211515 | NA |
| Product Code | LZA | LZA | Identical |
| Intended use | Nitrile Examination Glovesare disposable devicesintended for medicalpurpose that are worn on theexaminer's hand to preventcontamination betweenpatient and examiner. | Beijing Reagent LatexProducts Co., Ltd NitrileExamination Gloves aredisposable devices intendedfor medicalpurpose that are worn onthe examiner's hand toprevent contaminationbetween patient andexaminer. | Identical |
| Dimensions | Extra-Small:Length: Minimum 220mmWidth: $70\pm10$ mmSmall:Length: Minimum 220mm | Extra-Small:NoneSmall:Length: Minimum 220mm | Different 1 |
| Width: 80±10mm | Width: 80±10mm | ||
| Medium: | Medium: | ||
| Length: Minimum 230mm | Length: Minimum 230mm | ||
| Width: 95±10mm | Width: 95 ± 10mm | ||
| Large: | Large: | ||
| Length: Minimum 230mm | Length: Minimum 230mm | ||
| Width: 110±10mm | Width: 110±10mm | ||
| Extra- Large: | Extra- Large: | ||
| Length: Minimum 230mm | Length: Minimum 230mm | ||
| Width: 120±10mm | Width: 120±10mm | ||
| Palm thickness: | Palm thickness: | ||
| Thickness perASTM D6319(for all sizes) | Minimum 0.05 mm | Minimum 0.05 mm | Identical |
| Finger thickness: Minimum0.05 mm | Finger thickness: Minimum0.05 mm | ||
| Tensile Strength: | Tensile Strength: | ||
| Physical PropertiesBefore Aging perASTM D6319 | Minimum 14 MPa | Minimum 14 MPa | Identical |
| Ultimate Elongation:Minimum 500% | Ultimate Elongation:Minimum 500% | ||
| Tensile Strength: | Tensile Strength: | ||
| Physical PropertiesAfter Aging perASTM D6319 | Minimum 14 MPa | Minimum 14 MPa | Identical |
| Ultimate Elongation:Minimum 400% | Ultimate Elongation:Minimum 400% | ||
| Water tight (holedetection) perASTM D5151 | Passes at AQL of 2.5 | Passes at AQL of 2.5 | Identical |
| Powder Residueper ASTM D6319 | ≤2 mg/glove | ≤2 mg/glove | Identical |
| Biocompatibility:Primary SkinIrritation per ISO10993-10 | Not an irritant under theconditions of the study. | Not an irritant under theconditions of the study. | Identical |
| Biocompatibility:DermalSensitizationper ISO 10993-10 | Not a sensitizer under theconditions of the study. | Not a sensitizer under theconditions of the study. | Identical |
| Biocompatibility:Acute SystemicToxicity Test perISO 10993-11 | Device extracts do notpose a systemic toxicityconcern under theconditions of the study | Device extracts do notpose a systemic toxicityconcern under theconditions of the study | Identical |
| Device Material | Nitrile | Nitrile | Identical |
| Color | Blue | Blue | Identical |
| Size Offering | Extra-Small, Small,Medium, Large, Extra-Large | Small, Medium, Large, Extra-Large | Different 1 |
| Number of Uses | Single Use | Single Use | Identical |
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Different 1:
The models of proposed device are different with predicate device, but all proposed devices are meet the specifications of ASTM D 6319. So we consider this as the proposed device is similar to the predicate device.
IX Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission K213739, Nitrile Examination Gloves, is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Snow Lotus Nitrile Examination Gloves, cleared under 510(k) K211515.
§ 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.