(85 days)
Not Found
No
The device is a simple physical barrier (nitrile gloves) and the summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device, disposable medical nitrile examination gloves, is intended to prevent contamination and protect hands, not to treat or cure a disease or condition.
No
The device, Disposable Medical Nitrile Examination Gloves, is described as a protective barrier worn on the hand to prevent contamination and is not intended for the purpose of diagnosis.
No
The device description clearly states it is a physical product (gloves made of nitrile latex) and the performance studies are bench tests on the physical properties of the gloves, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to prevent contamination between patient and examiner" by being worn on the examiner's hand. This is a barrier function, not a diagnostic one.
- Device Description: The description focuses on the material (nitrile latex) and its physical properties and standards (ASTM D6319, etc.). There is no mention of analyzing samples from the human body or providing diagnostic information.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The device is clearly described as a medical device (specifically, a disposable medical glove) intended for protection and contamination prevention.
N/A
Intended Use / Indications for Use
Disposable Medical Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
The Disposable Medical Nitrile Examination Gloves are manufactured to meet the all current specifications listed under the ASTM Specification D6319 - 19, Standard Specification for Nitrile Examination Gloves for Medical Application. Disposable Medical Nitrile Examination Gloves are mainly composed of nitrile latex. It is mainly suitable for hand protection during medical examination. These gloves are powder free.
The proposed device(s) are orange color and sold non-sterile and are intended to be single-use, disposable devices.
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)
Bench tests were conducted to demonstrate that the proposed device complies with the following standards:
ISO 10993-10: 2021 Biological Evaluation of Medical Devices - Part 10: Tests For Skin Sensitization.
ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D6124-06 (R2017) Standard Test Method for Residual Powder on Medical Gloves ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves
Physical Dimensions: The subject device complies with the dimension requirements prescribed in ASTM D6319-19.
Physical Property Characteristics: Before and after accelerated aging, the subject device complies with the physical requirements specified in ASTM D6319-19 Table 3.
Freedom From Holes: No water leakage is inspected. The subject device complies with the requirements specified in ASTM D5151.
Residual Powder: Residual Powder less than 2 mg per glove. The subject device complies with the requirements specified in ASTM D6124.
Acute Systemic Toxicity: The test article has no potential acute system toxicity on ICR mice in the extraction method.
Skin Irritation: Under the experimental conditions, the test article has no skin irritation on rabbits.
Skin Sensitization: The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig.
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 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 23, 2023
Hebei Titans Hongsen Medical Technology Co., Ltd. % Ray Wang General Manager Beijing Believe Technology Service Co., Ltd. Rm. 912 Building #15. XiYueHui. No.5. YiHe North Rd., FangShan District Beijing, Beijing 102401 China
Re: K223895
Trade/Device Name: Disposable Medical 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 28, 2022 Received: December 28, 2022
Dear Ray 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.
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); 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.
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. 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) K223895
Device Name
Disposable Medical Nitrile Examination Gloves
Indications for Use (Describe)
Disposable Medical Nitrile Examination Gloves are disposable device intended for medical purpose that is 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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3
K223895 510(k) Summary
-
- Date of Preparation: 2023/03/22
-
- Submitter
Hebei Titans Hongsen Medical Technology Co., Ltd.
Eastern Industrial Zone, Nangong City, Xingtai City, 051800, Hebei, China Contact Person: Xiaojing Zhao Position: Office clerk Tel: +86-13383292209 Email: sara@titans-cn.com
-
- Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401 Contact Person: Ray Wang Position: General Manager Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com
-
- Subject Device Identification
510(k) Number: K223895
- Subject Device Identification
Trade Name: Disposable Medical Nitrile Examination Gloves
Common Name: Polymer Patient Examination Glove
Regulatory Information: Classification: I Product Code: LZA Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital
4
- న్. Predicate Device Identification
510(k) Number: K222498
Product Name: Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)
Manufacturer: Humanwell Healthcare Group Medical Supplies Co., Ltd
Regulatory Information:
Classification: I
Product Code: LZA
Regulation Number: 21 CFR 880.6250
Review Panel: General Hospital
Common Name: Polymer Patient Examination Glove
-
- Device Description
The Disposable Medical Nitrile Examination Gloves are manufactured to meet the all current specifications listed under the ASTM Specification D6319 - 19, Standard Specification for Nitrile Examination Gloves for Medical Application. Disposable Medical Nitrile Examination Gloves are mainly composed of nitrile latex. It is mainly suitable for hand protection during medical examination. These gloves are powder free.
- Device Description
The proposed device(s) are orange color and sold non-sterile and are intended to be single-use, disposable devices.
-
Indication For Use Statement 7.
Disposable Medical Nitrile Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. -
Technological Characteristic Comparison Summary 8.
| ITEM | Proposed Device (K223895)
Disposable Medical Nitrile Examination
Gloves | Predicate Device (K222498)
Medical Examination Gloves (Nitrile) (XS,
S, M, L, XL) | Remark |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | LZA | LZA | SAME |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | SAME |
| Class | I | I | SAME |
| Intended Use | Disposable Medical Nitrile Examination
Gloves are disposable device intended for
medical purpose that is worn on the
examiner's hand to prevent contamination
between patient and examiner. | The Medical Examination Glove (Nitrile) is
a disposable device intended for medical
purposes that is worn on the examiner's
hand to prevent contamination between
patient and examiner. | SAME |
| Powder free | Yes | Yes | SAME |
Table 1 General Comparison
5
| Design feature | Ambidextrous | Ambidextrous | SAME |
|---|---|---|---|
| Material | Nitrile | Nitrile | SAME |
| OTC use | Yes | Yes | SAME |
| Sterility | Non-sterile | Non-sterile | SAME |
| Use | Single use | Single use | SAME |
| Label | Single-use, indication, powder free, device color, device name, glove size and quantity, Nitrile Glove Powder Free orange, Non-Sterile | Single-use, indication, powder free, device color, device name, glove size and quantity, Nitrile Glove Powder Free Blue, Non-Sterile | SAME |
Table 2 Device Dimensions Comparison
| Proposed Device (K223895)
Disposable Medical Nitrile
| Examination Gloves | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| Length, mm | XS | ||||||
| 230 | S | ||||||
| 230 | M | ||||||
| 230 | L | ||||||
| 230 | XL | ||||||
| 230 | min | ||||||
| Width, mm | 70 | 80 | 95 | 110 | 120 | $\pm$ 10 | |
| Thickness, mm: | |||||||
| Finger | 0.1 | $\pm$ 0.03 | |||||
| Palm | 0.08 | $\pm$ 0.03 | |||||
| Cuff | 0.07 | $\pm$ 0.03 | |||||
| Predicate Device (K222498) | |||||||
| Medical Examination Gloves | |||||||
| (Nitrile) (XS, S, M, L, XL) | Designation | Size | Tolerance | ||||
| Length, mm | XS | ||||||
| 220 | S | ||||||
| 220 | M | ||||||
| 230 | L | ||||||
| 230 | XL | ||||||
| 230 | min | ||||||
| Width, mm | 70 | 80 | 95 | 110 | 120 | $\pm$ 10 | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Cuff | unavailable | min | |||||
| Remark | Similar |
Analysis:
The proposed device has different size specification to the predicate device, but all proposed devices are meet the specifications of ASTM D 6319. So the difference does not affect the substantial equivalence in effectiveness and safety.
| ITEM | Proposed Device (K223895)
Disposable Medical Nitrile Examination Gloves | Predicate Device (K222498)
Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) | Remark | |
|------------------------|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|------|
| Colorant | Orange | Blue | Different | |
| Physical
Properties | Before Aging
Tensile Strength | 14 MPa, min | 14 MPa, min | SAME |
| | Ultimate Elongation | 500 % min | 500 % min | SAME |
| | After Aging
Tensile Strength | 14 MPa, min | 14 MPa, min | SAME |
| | Ultimate Elongation | 400 % min | 400 % min | SAME |
| Freedom from Holes | | Comply with ASTM D6319
Be free from holes when tested
in accordance with ASTM
D5151
G-1, AQL 1.5 | Comply with ASTM D6319
Be free from holes when tested
in accordance with ASTM
D5151
G-1, AQL 1.5 | SAME |
| Residual Powder | | Meet the
requirements of
ASTM D6124 | Meet the
requirements of
ASTM D6124 | SAME |
Table 3 Performance Comparison
Analysis:
The subject device has different colour to the predicate device. The colour of the proposed device is orange and predicate device is Blue. But the Biocompatibility testing was successfully completed for the subject device, demonstrating that the difference does not affect the substantial equivalence in effectiveness and safety.
6
| ITEM | Proposed Device (K223895)
Disposable Medical Nitrile
Examination Gloves | Predicate Device (K222498)
Medical Examination Gloves
(Nitrile) (XS, S, M, L, XL) | Remark |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|--------|
| Material | Nitrile | Nitrile | SAME |
| Biocompatibility | Irritation
Under the conditions of the
study, not an irritant | Under the conditions of the
study, not an irritant | SAME |
| | Sensitization
Under conditions of the
study, not a sensitizer. | Under conditions of the
study, not a sensitizer. | SAME |
| | acute
systemic
toxicity
Under the conditions of the
study, there was no evidence
of systemic toxicity from the
extract. | Under the conditions of the
study, there was no evidence
of systemic toxicity from the
extract. | SAME |
| Label and Labeling | Meet FDA's Requirements | Meet FDA's Requirements | SAME |
Analysis:
We have conducted the testing according to the ISO10993-1, Acute Systemic Toxicity, irritation and sensitization. The test results shown that no biocompatibility risk would be raised. So, we consider that the proposed device has same biocompatibility performance with the predicate device.
Summary of Non-Clinical Testing 9.
Bench tests were conducted to demonstrate that the proposed device complies with the following standards:
ISO 10993-10: 2021 Biological Evaluation of Medical Devices - Part 10: Tests For Skin Sensitization.
ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application ASTM D6124-06 (R2017) Standard Test Method for Residual Powder on Medical Gloves ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves
| Title of the test | Purpose of the test | Acceptance criteria and
the source of references | Results |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical
Dimensions | Detection of the conformity
that whether the gloves
whether the dimension
requirements prescribed in
ASTM 6319-19 Table 2. | ASTM D6319-19
Standard Specification for
Nitrile Examination
Gloves. | The subject device complies
with the dimension
requirements prescribed in
ASTM D6319-19. |
| Physical
Property
Characteristics | Detection of the conformity that
whether the gloves meet the
requirements specified in ASTM
D6319-19 Table 3, before and
after accelerated aging. | ASTM D412 Standard Test
Methods for Vulcanized
Rubber and Thermoplastic
Elastomers-Tension | Before and after
accelerated aging, the
subject device complies
with the physical
requirements specified in
ASTM D6319-19 Table
3. |
| Freedom From
Holes | Detection of holes that allow
water leakage under the
conditions of the test. | ASTM D5151-06,
Standard Test Method for
Detection of Holes in
Medical Gloves. | No water leakage is
inspected.
The subject device
complies with the
requirements specified in
ASTM D5151. |
| Residual | Determine the amount of | Residual Powder less | Residual Powder less than |
Table 5 Bench Tests Summary
7
| Powder | residual powder found on a
sample of medical gloves. | than 2 mg per glove as
required in ASTM D
6124-06, R2017,
Standard Test Method for
Residual Powder on
Medical Gloves. | 2 mg per glove.
The subject device
complies with the
requirements specified in
ASTM D6124. |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Acute
Systemic
Toxicity | The test was designed to
evaluate the potential acute
system toxicity caused by test
article contact with the ICR
mice and extrapolating the
results to humans. | ISO 10993-11 Biological
evaluation of medical
devices - Part 11: Tests
for systemic toxicity. | The test article has no
potential acute system
toxicity on ICR mice in
the extraction method. |
| Skin Irritation | To evaluate the potential skin
irritation caused by test article
contact with the skin surface
of rabbits and extrapolating
the results to humans, but it
does not establish the actual
risk of irritation. | ISO 10993-23: 2021
Biological evaluation of
medical devices - Part 23:
Tests for irritation. | Under the experimental
conditions, the test article
has no skin irritation on
rabbits. |
| Skin
Sensitization | The test was designed to
evaluate the potential of a test
article to cause skin
sensitization. The test is used
as a procedure for screening
of contact allergens in guinea
pigs and extrapolating the
results to humans, but it does
not establish the actual risk of
sensitization | ISO 10993-10: 2021
Biological Evaluation Of
Medical Devices - Part
10: Tests For Skin
Sensitization. | The test article showed
no evidence of causing
delayed dermal contact
sensitization in the
guinea pig. |
10. Summary of Clinical Testing
Not applicable
11. Conclusions
Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, Medical Examination Gloves (Nitrile) (XS, S, M, L, XL), cleared under K222498.