(223 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier protection of examination gloves, with no mention of AI or ML.
No
The device provides barrier protection and does not deliver therapy or treatment to a patient.
No
The device, Nitrile Examination Gloves, is described as a barrier to prevent contamination between patient and examiner. Its purpose is to provide protection rather than to diagnose a condition or disease.
No
The device is a physical product (nitrile examination gloves) and not software. The description focuses on material properties and physical performance standards.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be worn on the hands or fingers to prevent contamination between patient and examiner. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the material (nitrile), physical properties (barrier protection, tensile strength), and compliance with standards related to gloves. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: IVD devices typically involve reagents, instruments, or systems used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does none of that.
- Regulatory Classification: The device is classified under 21 CFR 880.6250, which is for Patient Examination Gloves, a Class I medical device. This classification is for general medical devices, not specifically for IVDs.
In summary, the Nitrile Examination Gloves are a barrier device used for infection control, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Nitrile Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger 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 patient examination gloves made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirements specifications for barrier protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. The subject device is powder free nitrile examination gloves. The subject device is in blue color.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (for medical purposes)
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 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
Summary of non-clinical performance testing:
ASTM D6319 Physical Dimensions Test:
Length(mm): >= 230; Results: Length: >= 230; Pass
Width(mm): S: 80 +/- 10; Results: Width: S: 80-84; Pass
M: 95 +/- 10; Results: M: 95-99; Pass
L: 110 +/- 10; Results: L: 108-111; Pass
XL: 120 +/- 10; Results: XL: 117-121; Pass
Thickness (mm): Finger: >= 0.05; Results: Finger: 0.08-0.10; Pass
Palm: >= 0.05; Results: Palm: 0.06-0.08; Pass
ASTM D5151 Watertightness Test for Detection of Holes:
Meet the requirements of ASTM D5151 AQL 2.5; Results: 0/125 leaks; Pass
ASTM D6124 Powder Content:
Meet the requirements of ASTM D6124 = 14 MPa; Results: 26-35; Pass
Ultimate Elongation: >= 500 %; Results: 509-545; Pass
After Aging:
Tensile Strength: >= 14 MPa; Results: 19-36; Pass
Ultimate Elongation: >= 400 %; Results: 447-510; Pass
ISO 10993-5 Cytotoxicity:
cytotoxic; Results: Under conditions of the study, show slight potential toxicity to L-929 cells.
ISO 10993-11 Acute systemic toxicity test:
Non-toxicity; Results: Under the condition of acute systemic toxicity test, the test article did not show acute systemic toxicity in vivo.; Pass
ISO 10993-10 Irritation:
Non-irritating; Results: Under the conditions of the study, not an irritant/ Pass
ISO 10993-10 Sensitization:
Non-sensitizing; Results: Under conditions of the study, not a sensitizer./ Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
October 19, 2021
Niujian Technology Co., Ltd. Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong, Shanghai, 200120 CHN
Re: K210706
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: September 6, 2021 Received: September 14, 2021
Dear Boyle Wang:
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.
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
1
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 (OS) 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,
For 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) K210706
Device Name Nitrile Examination Gloves
Indications for Use (Describe)
The Nitrile Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
escription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary (K210706)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
Date Prepared: October 5, 2021
1.0 Submission Sponsor
| Manufacturer Name | Niujian Technology Co., Ltd. |
|---|---|
| Address | Room 401 Building 1, Anfangcheng No. 919, East |
| Qunxian Road, Yuecheng District, Shaoxing, Zhejiang | |
| Tel | 86-18210518920 |
| 385206015@qq.com | |
| Contact Person | Xiuqiang Zhou |
Designated Submission Correspondent
| Company Name | Shanghai Truthful Information Technology Co., Ltd |
|---|---|
| Address | Room 1801, No. 161 East Lujiazui Rd., Pudong, |
| Shanghai 200120, China | |
| Tel | +86-21-50313932 |
| Info@truthful.com.cn | |
| Contact Person: | Mr. Boyle Wang |
2.0 Device Identification
| Classification Name | Polymer Patient Examination |
|---|---|
| Glove Trade Name | Nitrile Examination Gloves |
| Device Classification | Class I |
| Regulation Number | 21 CFR 880.6250 |
| Panel | General Hospital |
| Product Code | LZA |
| Previous Submissions | None |
3.0 Classification
Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I
4
Panel: General Hospital
4.0 Predicate Device Information
Ever Growth (Vietnam) Co., Ltd. Sponsor: Device: Disposable Powder Free Nitrile Examination Glove, Pink Color Disposable Powder Free Nitrile Examination Glove, Black Color 510(k) number: K190942
5.0 Indication for Use
The Nitrile Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.
6.0_Device Description
Nitrile Examination Gloves are patient examination gloves made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirements specifications for barrier protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. The subject device is powder free nitrile examination gloves. The subject device is in blue color.
7.0 Technological Characteristic Comparison Table
| Item | Subject Device
(K210706) | Predicate Device
(K190942) |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LZA | LZA |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 |
| Class | I | I |
| Intended Use | The Nitrile Examination
Gloves are non-sterile
disposable device intended
for medical purposes that are
worn on the examiner's
hands or finger to prevent
contamination between
patient and examiner. | The Nitrile Powder Free
patient examination glove is a
non-sterile disposable device
intended for medical purposes
that is worn on the examiner's
hands or finger to prevent
contamination between patient
and examiner. |
Table1-General Comparison
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| Material | Nitrile | Nitrile | |||
|---|---|---|---|---|---|
| Powdered or | |||||
| Powered free | Powdered free | Powdered free | |||
| Design Feature | Ambidextrous | Ambidextrous | |||
| Colorant | Blue | Blue | |||
| Labeling Information | Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile | Single-use indication, powder free, device color, device name, glove size and quantity, Non-Sterile | |||
| Dimensions(mm) | Complies with ASTM D6319-19: | ||||
| Length: $\ge$ 230; | |||||
| Width: | |||||
| S: 80 $\pm$ 10; | |||||
| M: 95 $\pm$ 10; | |||||
| L: 110 $\pm$ 10; | |||||
| XL: 120 $\pm$ 10 | Complies with ASTM D6319-19: | ||||
| Length: $\ge$ 230; | |||||
| Width: | |||||
| XS:70 $\pm$ 10; | |||||
| S: 80 $\pm$ 10; | |||||
| M: 95 $\pm$ 10; | |||||
| L: 110 $\pm$ 10; | |||||
| XL: 120 $\pm$ 10 | |||||
| Thickness(mm) | Complies with ASTM D6319-19: | ||||
| Finger: $\ge$ 0.05; | |||||
| Palm: $\ge$ 0.05 | Complies with ASTM D6319-19: | ||||
| Finger: $\ge$ 0.05; | |||||
| Palm: $\ge$ 0.05 | |||||
| Physical | |||||
| Properties | Before | ||||
| Aging | Tensile | ||||
| Strength | 14MPa, min | Tensile | |||
| Strength | 14MPa, min | ||||
| Ultimate | |||||
| Elongation | 500% min | Ultimate | |||
| Elongation | 500% min | ||||
| After | |||||
| Aging | Tensile | ||||
| Strength | 14MPa, min | Tensile | |||
| Strength | 14MPa, min | ||||
| Ultimate | |||||
| Elongation | 400%min | Ultimate | |||
| Elongation | 400%min | ||||
| Freedom from | |||||
| Holes | In accordance with ASTM | ||||
| D6319-19 and ASTM D5151- | |||||
| 19, G-1, AQL 2.5 | In accordance with ASTM | ||||
| D6319-19 and ASTM D5151- | |||||
| 19, G-1, AQL 2.5 | |||||
| Powder Content | Complies with ASTM D6319- | ||||
| 19: |