(113 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety standards of examination gloves, with no mention of AI or ML.
No
The device, Disposable Nitrile Examination Gloves, is intended to prevent contamination between patient and examiner, not to treat or cure a disease or condition.
No
Explanation: The device, Disposable Nitrile Examination Gloves, is intended to prevent contamination between patient and examiner and does not perform any diagnostic function.
No
The device is a physical product (gloves) and the description focuses on material properties and performance standards related to physical characteristics, 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. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description is of a physical glove, not a reagent, instrument, or system used for testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Disposable Nitrile Examination Gloves 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
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner, 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.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.
April 20, 2021
Jiangsu Yanfang Medical Technology Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K203805
Trade/Device Name: Disposable 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: December 23, 2020 Received: December 28, 2020
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
1
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 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,
Ryan Ortega, PhD 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203805
Device Name Disposable Nitrile Examination Gloves
Indications for Use (Describe)
The Disposable Nitrile Examination Gloves 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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3
510(k) Summary (K203805)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Jiangsu Yanfang Medical Technology Co., Ltd. Address: No.16, Kaiyuan Road, Changjing Town, Jiangyin, Wuxi, Jiangsu, China 214411 Phone Number: +86- 13812992152 Contact: Wei Kaijian Date of Preparation: Apr.20,2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Disposable Nitrile Examination Gloves Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): XL/L/M/S
3.0 Classification
Production code: LZA Requlation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
Ever Global (Vietnam) Enterprise Corp Manufacturer: Disposable Powder Free Nitrile Examination Glove, White/ Device:
4
Blue/ Black/ Pink Color 510(k) number: K171422
5.0 Indication for Use
The Disposable Nitrile Examination Gloves is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
6.0 Device Description
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
7.0 Technological Characteristic Comparison Table
| Item | Subject Device
(K203805) | Predicated Device
(K171422) | Remark |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Disposable
Nitrile Examination
Gloves is intended
for medical
purposes that is
worn on the
examiner's hands
to prevent
contamination
between patient
and examiner. | The Disposable
Powder Free Nitrile
Examination Glove,
White/ Blue/ Black/
Pink Color is a
disposable device
intended for
medical purposes
that is worn on the
examiner's hands
to prevent
contamination
between patient
and examiner. | Same |
| Powdered or
Powered free | Powdered free | Powdered free | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Sterility | Non sterile | Non sterile | Same |
| Labeling Information | Single-use
indication, powder
free, device color,
device name | Single-use
indication, powder
free, device color,
device name, glove | Same |
Table1-General Comparison
5
| | glove size and
quantity, Nitrile
Glove Powder
Free Blue, Non-
Sterile | size and quantity,
Disposable Powder
Free Nitrile
Examination Glove,
Non-Sterile |
| -- | ----------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------- |
|---|
Table2 Device Dimensions Comparison
| Designation | Size | Tolerance | |||||
|---|---|---|---|---|---|---|---|
| Predicate | |||||||
| Device(K171422) | Length, mm | XS | |||||
| 230 | S | ||||||
| 230 | M | ||||||
| 230 | L | ||||||
| 230 | XL | ||||||
| 230 | min | ||||||
| Width, mm | 75 | 85 | 95 | 105 | 115 | $\pm 5$ | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Subject Device | |||||||
| (K203805) | Designation | ||||||
| Length, mm | S | ||||||
| 220 | M | ||||||
| 230 | L | ||||||
| 230 | XL | ||||||
| 230 | min | ||||||
| Width, mm | 80 | 95 | 110 | 120 | $\pm 10$ | ||
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Remark | Similar |
Analysis: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319-19,so the differences do not raise any new safety or performance questions.
Table3 Performance Comparison
| Item | Subject device
(K203805) | Predicated device
(K171422) | Remark | | |
|------------------------|-----------------------------|--------------------------------|------------------------------|------------|------|
| Colorant | Blue | White/ Blue/
Black/ Pink | Similar | | |
| Physical
Properties | Before
Aging | Tensile
Strength | 14MPa, min | 14MPa, min | Same |
| | | Ultimate
Elongation | 500% min | 500% min | Same |
| | After
Aging | Tensile
Strength | 14MPa, min | 14MPa, min | Same |
| | | Ultimate
Elongation | 400%min | 400%min | Same |
| Physical
Properties | Comply with ASTM D6319 | | Comply with
ASTM
D6319 | Same | |
6
| Freedom from Holes | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | Same |
|---|---|---|---|
| Powder Content | Meet the requirements of ASTM D6124 | Meet the requirements of ASTM D6124 | Same |
Analysis: The subject device is only available in a single color (blue,) however, the predicate is available in multiple colors (white, blue, black, pink). Biocompatibility testing was successfully completed for the subject device, demonstrating that any color differences do not affect the safety of the proposed device.
| Table4 Safety Comparison | ||||
|---|---|---|---|---|
| Item | Subject device | |||
| (K203805) | Predicated device | |||
| (K171422) | Remark | |||
| Material | Nitrile | Nitrile | Same | |
| Biocompatibility | Irritation (ISO 10993-10:2010 | |||
| Biological | ||||
| Evaluation of | ||||
| Medical Devices - | ||||
| Part 10: Tests For | ||||
| Irritation And Skin | ||||
| Sensitization) | Under the | |||
| conditions of | ||||
| the study, not | ||||
| an irritant. | ||||
| Complies with | ||||
| ISO-10993-10. | Same | |||
| Sensitization | ||||
| (ISO 10993- | ||||
| 10:2010 | ||||
| Biological | ||||
| Evaluation of | ||||
| Medical Devices - | ||||
| Part 10: Tests For | ||||
| Irritation And Skin | ||||
| Sensitization) | Under | |||
| conditions of | ||||
| the study, not a | ||||
| sensitizer. | ||||
| Complies with | ||||
| ISO-10993-10. | Comply with | |||
| ISO10993-10 | ||||
| Cytotoxicity (ISO | ||||
| 10993-5:2009 | ||||
| Biological | ||||
| Evaluation of | ||||
| Medical Devices - | ||||
| Part 5: Tests For | ||||
| In Vitro | Under the | |||
| conditions of | ||||
| the study, not | ||||
| cytotoxic. | ||||
| Complies with | ||||
| ISO-10993-5. | / | Different |
Table4 Safety Comparison
7
| Cytotoxicity) | ||
|---|---|---|
| - |
Analysis: Cytotoxicity information for the predicate device is not publicly available. This does not raise different safety or performance questions since the subject device has acceptable biocompatibility per the biocompatibility endpoint assessment.
8.0 Discussion of Non-clinical and Performance Testing
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.
9.0 Discussion of Clinical and Performance Testing
Clinical testing is not needed for this device.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device in K203805, Disposable Nitrile Examination Gloves ,is as safe, as effective, and performs as well as or better than the legally marketed predicated device cleared under K171422.