(205 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of examination gloves, with no mention of AI or ML technology.
No
The device, Nitrile Examination Gloves, is described as preventing contamination between patient and examiner, which is a barrier function, not a therapeutic action. It does not treat or cure a disease or condition.
No
Explanation: The device, Nitrile Examination Gloves, is described as a disposable device worn on the hand to prevent contamination. Its performance studies focus on physical properties and biocompatibility, not on detecting, diagnosing, or monitoring diseases or conditions.
No
The device description clearly states it is a physical product (gloves made of Nitrile rubber) and the performance studies focus on physical properties and biocompatibility, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the material, color, size, and sterility of the gloves, all related to their physical barrier purpose.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.), detect biomarkers, or provide information for diagnosing a disease or condition.
- Performance Studies: The performance studies focus on physical properties (tensile strength, watertightness) and biocompatibility, which are relevant to a barrier device, not a diagnostic one.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This description does not align with the function of examination gloves.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
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.
The subject device is non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- ASTM D5151 Standard Test Method for Detection of Holes in Medical Gloves
- 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
- ISO 10993-11: 2017 Biological evaluation of medical devices-Part 11: Tests for systemic toxicity
Performance Tests and Results:
- Physical Dimensions Test (ASTM D6319):
- Extra-Small: Length: >=220mm; Width: 70+/-10 mm - Pass
- Small: Length: >= 220mm; Width: 80+/-10mm - Pass
- Medium: Length: >= 230mm; Width: 95+/-10mm - Pass
- Large: Length: >=230mm; Width: 110+/-10mm - Pass
- Extra- Large: Length: >=230mm; Width: 120+/-10mm - Pass
- Thickness (mm): Finger:>=0.05, Palm: >=0.05 - Pass
- Physical properties (ASTM D6319):
- Before Aging Tensile Strength: >=14MPa - Pass
- Before Aging Ultimate Elongation: >=500% - Pass
- After Aging Tensile Strength: >=14MPa - Pass
- After Aging Ultimate Elongation: >=500% - Pass
- Watertightness Test for Detection of Holes (ASTM D5151): Meet the requirements of ASTM D5151Test for AQL 2.5 - Pass
- Powder Content (ASTM D6124): Meet the requirements of ASTM D6124
§ 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.
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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
| Test
| Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| 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 | ||
| Before | |||
| Aging Ultimate Elongation | ≥500% | ||
| After | |||
| Aging Tensile Strength | ≥14MPa | ||
| After | |||
| Aging Ultimate Elongation | ≥500% | ||
| ASTM | |||
| D5151 | Watertightness | ||
| Test for Detection | |||
| of Holes | Meet the requirements of ASTM | ||
| D5151Test for AQL 2.5 | Pass |
Table 1 Summary of Non-Clinical Performance Testing
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| ASTM
D6124 | Powder Content | Meet the requirements of ASTM
D6124