(140 days)
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No
The device, a disposable nitrile examination glove, is intended to prevent contamination between patient and examiner, not to treat or alleviate a disease or condition.
No
The device is a medical glove intended to prevent contamination, not to diagnose any condition.
No
The device description clearly states the device is a physical product (nitrile examination gloves) and the performance studies focus on physical and biological properties, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as being worn on the examiner's hands to prevent contamination between patient and examiner. This is a barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description is of a physical barrier (a glove).
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical properties of the glove (freedom from holes, dimensions, aging) and biological compatibility (cytotoxicity, irritation, sensitization, systemic toxicity), which are relevant for a medical device worn on the body, but not for an IVD.
- No Mention of Diagnostic Metrics: There are no mentions of metrics like sensitivity, specificity, PPV, or NPV, which are standard for evaluating the performance of diagnostic tests.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
The Disposable Medical Nitrile Examination Glove is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
The subject device is powder free nitrile examination gloves. The subject device is blue. 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. The test results demonstrated that the proposed device: complies with the following standards:
- ISO 10993-5: Biological Evaluation of Medical Devices Part 5: Tests For In Vitro A Cytotoxicity.
- ISO 10993-10: Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ISO 10993-11: Biological Evaluation of Medical Devices - Part 11: Tests For Tests for Systemic Toxicity.
- ASTM D5151: Standard Test Method for Detection of Holes in Medical Gloves.
- D6319: Standard Specification for Nitrile Examination Gloves for Medical Application.
Results:
- ISO 10993-5: Pass (Non-cytotoxic)
- ISO 10993-11: Pass (Does not cause systemic toxicity)
- ISO 10993-10 (Irritation): Pass (Non-irritant, and Non skin irritant)
- ISO 10993-10 (Sensitization): Pass (Does not cause skin sensitization)
- ASTM D6319: Pass (Freedom from holes: Shall not leak; Physical dimensions for size L (mm): Width: 110 +/- 10, Length: >= 230, Finger and palm thickness: median value >= 0.05; After Aging: Tensile Strength: >= 14 MPa, Ultimate elongation: >400%)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 16, 2021
Taizhou Kangjian Medical Equipments Co., Ltd. % Helen Nan General Manager Cytech (Shenzhen) Enterprise Management Consulting Co.,Ltd. Room302, Building3, Hangqian Mansion, Hangqian Street, Lucheng District Wenzhou, Zhejiang 325000 China
Re: K212029
Trade/Device Name: Disposable Medical Nitrile Examination Gloves (non-sterile) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: October 13, 2021 Received: October 13, 2021
Dear Helen Nan:
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.
1
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 and Part 809); 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,
Clarence W. Murray, III, PhD 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
2
Indications for Use
510(k) Number (if known) K212029
Device Name
Disposable Medical Nitrile Examination Gloves (non-sterile)
Indications for Use (Describe)
The Disposable Medical Nitrile Examination Glove is intended for medical purposes that is worn on the examiner's hands 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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Image /page/3/Picture/0 description: The image shows a logo with the word "HEPING" in red letters. Above the word are three red shapes that appear to be stylized letters or symbols. The first shape looks like two parallel lines, the second shape is a diagonal line with a dot on top, and the third shape is a curved shape. Below the word "HEPING" are two Chinese characters, also in red.
Taizhou Kangjian Medical Equipments Co., Ltd. The Machine Electricity Zone (Hang Ni Kan) of Yuhuan County, Zhejiang, 317600, CHINA.
510(k) Summary K212029
1.0 Submitter Information
| Company: | Taizhou Kangjian Medical Equipments Co., Ltd. |
|---|---|
| Address: | The Machine Electricity Zone (Hang Ni Kan) of |
| Yuhuan County, Zhejiang, 317600, CHINA. | |
| Phone: | 86-576-87299799 |
| Contact Person: | Hua Cong |
| Title: | Management Representative |
| E-mail: | webmaster@kangjiancn.com |
| Date of Preparation: | November 04, 2021 |
2.0 Device Information
| Trade/Device Name: | Disposable Medical Nitrile Examination Gloves |
|---|---|
| (non-sterile) | |
| Regulation Description: | Non-powdered patient examination glove. |
| Device: | Polymer Patient Examination Glove |
| Review Panel: | General Hospital |
| Product Code: | LZA |
| Regulation Number: | 21 CFR 880.6250 |
| Device Class: | Class I |
3.0 Predicate Device Information
| Trade/Device Name: | Nitrile Glove Powder Free Blue |
|---|---|
| 510k Number: | K210145 |
| Submitter: | Changzhou Universal Medical Equipment Co.Ltd |
4.0 Device Description
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
5.0 Indications for Use
The Disposable Medical Nitrile Examination Gloves is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
4
Image /page/4/Picture/0 description: The image is a logo with red text and symbols. The top portion of the logo features stylized, curved lines that resemble the letters 'H' and 'P'. Below these symbols, the word 'HEPING' is written in English, flanked by two Chinese characters. The overall design is simple and bold, with a focus on the brand name.
Taizhou Kangjian Medical Equipments Co., Ltd.
The Machine Electricity Zone (Hang Ni Kan) of Yuhuan County, Zhejiang, 317600, CHINA.
6.0 Technological Characteristics
Table 1 - General Comparison
| Item | Predicate Device | Proposed Device | Comparison |
|---|---|---|---|
| Manufacturer | Changzhou Universal | ||
| Medical Equipment | |||
| CO. LTD. | Taizhou Kangjian | ||
| Medical Equipments | |||
| Co., Ltd. | N/A | ||
| 510K Number | K210145 | K212029 | N/A |
| Trade/Device | |||
| Name | Nitrile Glove Powder | ||
| Free Blue | Disposable Medical | ||
| Nitrile Examination | |||
| Gloves (non sterile) | N/A | ||
| Product Code | LZA | Same | |
| Classification | Class I | ||
| (21 CFR 880.6250) | Same | ||
| Intended Use | The Nitrile Glove | ||
| Powder Free Blue is a | |||
| disposable device | |||
| intended for medical | |||
| purposes that is | |||
| worn on the examiner's | |||
| hands to prevent | |||
| contamination between | |||
| patient and examiner. | The Disposable | ||
| Medical Nitrile | |||
| Examination Gloves is | |||
| intended for medical | |||
| purposes that is worn on | |||
| the examiner's hands to | |||
| prevent contamination | |||
| between | |||
| patient and examiner. | Same | ||
| Design | |||
| Feature | Ambidextrous | Ambidextrous | Same |
| Sterility | Non sterile | Non sterile | Same |
| Labeling | |||
| Information | Single-use indication, | ||
| powder free, device | |||
| color, device name, | |||
| glove size and quantity, | |||
| Nitrile Glove | |||
| Powder-Free, Non | |||
| Sterile | Single-use indication, | ||
| powder free, device | |||
| color, device name, | |||
| glove size and quantity, | |||
| Nitrile Glove | |||
| Powder-Free, Non | |||
| Sterile | Same |
Table 2 - Device Dimensions Comparison
| Item | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Length: | ≥230 mm | ≥220 mm | Same |
| Width: | 110 ± 10 mm | 110±10 mm | Same |
| Finger and | |||
| Palm | |||
| Thickness: | ≥0.05 mm | ≥0.05 mm | Same |
| Size | |||
| Statement | M | L | Different |
5
Image /page/5/Picture/0 description: The image shows a logo in red. The logo consists of stylized text and a symbol. The text includes the word "HEPING" in English, along with Chinese characters. The symbol is a curved line with a dot, resembling a stylized letter or design element.
Taizhou Kangjian Medical Equipments Co., Ltd.
The Machine Electricity Zone (Hang Ni Kan) of Yuhuan County, Zhejiang, 317600, CHINA.
Table 3 - Performance Comparison
| Device | Predicate Device | Proposed Device | Comparison | |
|---|---|---|---|---|
| Physical | ||||
| Properties | Before | |||
| Aging Tensile | ||||
| Strength | Not publicly | |||
| available | ≥14 MPa, | |||
| min | - | |||
| Before | ||||
| Aging Ultimate | ||||
| Elongation | Not publicly | |||
| available | ≥500% min | - | ||
| After | ||||
| Aging Tensile | ||||
| Strength | ≥14 MPa, | |||
| min | ≥14 MPa, | |||
| min | Same | |||
| After | ||||
| Aging Ultimate | ||||
| Elongation | ≥400% min | ≥400% min | Same | |
| Freedom from Holes | Be free from | |||
| holes | Be free from | |||
| holes | Same | |||
| Powder Content | Powered free | Powered free | Same |
Table 4 - Safety Comparison
| Device | Predicate
Device | Proposed
Device | Comparison | |
|------------------|-----------------------------------------|-------------------------------------------|-------------------------------------------|------|
| Colorant | Blue | Blue | Same | |
| Material | Nitrile | Nitrile | Same | |
| Biocompatibility | ISO 10993-5
Cytotoxicity | Non-cytotoxic | Non-cytotoxic | Same |
| | ISO
10993-10
Irritation | Non-irritant | Non-irritant | Same |
| | ISO
10993-10
Sensitization | Does not
cause skin
sensitization | Does not
cause skin
sensitization | Same |
| | ISO
10993-11
Systemic
Toxicity | Does not
cause
systemic
toxicity | Does not
cause
systemic
toxicity | Same |
7.0 Non-clinical Tests Performed on the Proposed Device
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device: complies with the following standards:
- ISO 10993-5: Biological Evaluation of Medical Devices Part 5: Tests For In Vitro A Cytotoxicity.
-
ISO 10993-10: Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- A ISO 10993-11: Biological Evaluation of Medical Devices - Part 11: Tests For Tests for Systemic Toxicity.
- A ASTM D5151: Standard Test Method for Detection of Holes in Medical Gloves.
6
Image /page/6/Picture/0 description: The image shows a logo in red. The logo consists of stylized text and a curved line. Below the stylized text is the word "HEPING" in English, with Chinese characters on either side.
Taizhou Kangjian Medical Equipments Co., Ltd.
The Machine Electricity Zone (Hang Ni Kan) of Yuhuan County, Zhejiang, 317600, CHINA.
-
D6319: Standard Specification for Nitrile Examination Gloves for Medical Application.
| Table 5 Relevant Standards and Test Results | |||
|---|---|---|---|
| Purpose | Acceptance Criteria | Results | |
| ISO 10993-5 | |||
| Biological evaluation | |||
| of medical devices | |||
| Test for in vitro | |||
| cytotoxicity | To determine the | ||
| potential cytotoxicity. | Non-cytotoxic | Pass | |
| ISO 10993-11 | |||
| Biological evaluation | |||
| of medical devices | |||
| Part 11: Tests for | |||
| Systemic Toxicity | To determine the | ||
| potential systemic | |||
| toxicity. | Does not cause systemic | ||
| toxicity. | Pass | ||
| ISO 10993-10 | |||
| Biological evaluation | |||
| on medical device Part | |||
| 10: Test for | |||
| Irritation and Skin | |||
| Irritation | To determine the | ||
| potential for irritation | |||
| and skin irritation. | Non-irritant, and Non | ||
| skin irritant. | Pass | ||
| ISO 10993-10 | |||
| Biological evaluation | |||
| on medical device Part | |||
| 10: Test Skin | |||
| Sensitization | To determine the | ||
| potential skin | |||
| sensitization. | Does not cause skin | ||
| sensitization. | Pass | ||
| ASTM D6319 | |||
| Standard Specification | |||
| for Nitrile | |||
| Examination Gloves | |||
| for Medical | |||
| Application | To test for: | ||
| (1) freedom from | |||
| holes | |||
| (2) physical | |||
| dimensions | |||
| (3) Aging | (1) Shall not leak | ||
| (2) For size L (mm): | |||
| Width: 110 $\pm$ 10 | |||
| Length: $\geq$ 230 | |||
| Finger and palm | |||
| thickness: median | |||
| value $\geq$ 0.05 | |||
| (3) After Aging: | |||
| Tensile Strength: $\geq$ 14 MPa | |||
| Ultimate elongation: | |||
| $>400%$ | Pass |
Table 5 Relevant Standards and Test Results
8.0 Clinical Tests Performed on the Proposed Device
Clinical testing was not required to support this device.
9.0 Conclusion
The conclusion drawn from the non-clinical tests demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.