(134 days)
No
The device is a simple medical glove and the summary contains no mention of AI or ML.
No
The device, examination gloves, is intended to prevent contamination, not to treat or cure a disease or condition.
No
Explanation: The device is described as examination gloves, intended to prevent contamination. There is no indication that it is used to diagnose any medical condition, disease, or injury.
No
The device is a physical product (gloves) and the description focuses on material properties and performance standards for a physical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This includes tests for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states the device is a "Medical Nitrile Examination Glove" intended to be "worn on the examiner's hands to prevent contamination between patient and examiner." This is a barrier device used externally, not for analyzing samples from the body.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, reagents, test kits, or any other components typically associated with IVD devices.
The device described is a standard medical glove, which is a Class I or Class II medical device depending on its intended use and claims, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Medical Nitrile Examination Gloves (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.
Product codes
LZA
Device Description
The proposed device is Powder Free Nitrile Examination Gloves and has different size specification and color.
The proposed device is provided in non-sterile.
The proposed device is made of Nitrile.
The proposed device has different size specification to the predicate device, but all proposed devices are meet the specifications of ASTM D6319
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 / 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
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-17, Standard Test Method for Residual Powder on Medical Gloves.
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.
Key Metrics
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 FDA logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health and Human Services logo is a stylized human figure, while the FDA part includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 10, 2021
Jiangxi Hongda Medical Equipment Group Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm. 912 Building #15, XiYueHui, No. 5, YiHe North Rd. FangShan District Beijing, Beijing 102401 China
Re: K210578
Trade/Device Name: Medical Nitrile Examination Gloves (Power free, Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA Dated: April 9, 2021 Received: April 13, 2021
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,
Jiangsong Jiang -S (Affiliate)
For Ryan Ortega 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
2
Indications for Use
510(k) Number (if known) K210578
Device Name
Medical Nitrile Examination Gloves (Powder free, Blue)
Indications for Use (Describe)
The Medical Nitrile Examination Gloves (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.
| 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
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number: K210578
-
- Date of Preparation: 07/09/2021
-
- Sponsor
Jiangxi Hongda Medical Equipment Group Ltd.
No. 39 South Shengli Road, Jinxian County, Nanchang City, JiangXi Province, 331700, China Contact Person: Yang Qinghua Position: Manager Tel: +86-18970093059 Fax: +86-791-85628888 Email: zkb(@jxhd.cn
-
- Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
- Submission Correspondent
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401
Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang(@believe-med.com
- Proposed Device Identification 4.
Trade Name: Medical Nitrile Examination Gloves (Powder free, Blue) Common Name: NITRILE Patient Examination Gloves (Powder Free)
Regulatory Information: Classification: I Product Code: LZA Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital
- Predicate Device Identification 5.
510(k) Number: K150340 Product Name: POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) Manufacturer: HEBEI HONGSEN PLASTICS TECHNOLOGY CO., LTD
4
- Device Description 6.
The proposed device is Powder Free Nitrile Examination Gloves and has different size specification and color.
The proposed device is provided in non-sterile.
The proposed device is made of Nitrile.
The proposed device has different size specification to the predicate device, but all proposed devices are meet the specifications of ASTM D6319
| Size Model | Cuff Thickness (mm) | Palm Thickness (mm) | Finger Thickness (mm) | Width (mm) | Length (mm) | Color |
|---|---|---|---|---|---|---|
| XS | $\ge$ 0.05 | $\ge$ 0.05 | $\ge$ 0.05 | 70±10 | $\ge$ 220 | Blue |
| S | $\ge$ 0.05 | $\ge$ 0.05 | $\ge$ 0.05 | 80±10 | ||
| U | $\ge$ 0.05 | $\ge$ 0.05 | $\ge$ 0.05 | 85±10 | $\ge$ 230 | |
| M | $\ge$ 0.05 | $\ge$ 0.05 | $\ge$ 0.05 | 95±10 | ||
| L | $\ge$ 0.05 | $\ge$ 0.05 | $\ge$ 0.05 | 110±10 | ||
| X-L | $\ge$ 0.05 | $\ge$ 0.05 | $\ge$ 0.05 | 120±10 | ||
| XX-L | $\ge$ 0.05 | $\ge$ 0.05 | $\ge$ 0.05 | 130±10 |
Table 1 Device Size Specifications
| Before Aging | After Aging | Pinhole AQL | ||
|---|---|---|---|---|
| Tensile | ||||
| Strength | Ultimate | |||
| Elongation | Tensile | |||
| Strength | Ultimate | |||
| Elongation | ||||
| 14 MPa, min | 500 % min | 14 MPa, min | 400 % min | 2.5 |
-
- Indications for Use: The proposed device, Medical Nitrile Examination Gloves (Powder free, Blue) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
- Comparison of technological characteristics between the predicate and subject devices 8.
Table 1 General Comparison
| ITEM | Proposed Device | Predicate Device (K150340) | Remark |
|---|---|---|---|
| Product Code | Medical Nitrile Examination Gloves | ||
| (Powder free, Blue) | POWDER FREE Nitrile GLOVES (White, | ||
| Cobalt Blue, Black, Ice Blue) | SAME | ||
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | SAME |
| Class | I | I | SAME |
5
| The Medical Nitrile Examination Gloves | The POWDER FREE Nitrile GLOVES | SAME | |
|---|---|---|---|
| Indications For | |||
| Use | (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. | (White, Cobalt Blue, Black, Ice Blue) 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 | |||
| Powder free | Powder free | Powder free | SAME |
Table 2 Device Dimensions Comparison
| Proposed Device
Medical Nitrile Examination
| Gloves (Powder free, Blue) | ||||||||
|---|---|---|---|---|---|---|---|---|
| Designation | XS | S | U | M | L | XL | XXL | Tolerance |
| Length, mm | 220 | 220 | 230 | 230 | 230 | 230 | 230 | min |
| Width, mm | 70 | 80 | 85 | 95 | 110 | 120 | 130 | ±10 |
| Thickness, mm: | ||||||||
| Finger | 0.05 | min | ||||||
| Palm | 0.05 | min | ||||||
| Cuff | 0.05 | min | ||||||
| Predicate Device (K150340) | ||||||||
| POWDER FREE Nitrile | ||||||||
| GLOVES (White, Cobalt Blue, | ||||||||
| Black, Ice Blue) | ||||||||
| Designation | XS | S | M | L | XL | Tolerance | ||
| Length, mm | 230 | 230 | 230 | 230 | 230 | min | ||
| Width, mm | 70 | 80 | 95 | 110 | 120 | ±10 | ||
| Thickness, mm: | ||||||||
| Finger | 0.10-0.12 | ±0.03 | ||||||
| Palm | 0.08-0.10 | ±0.03 | ||||||
| Cuff | 0.06-0.09 | ±0.03 |
Analysis 1:
The proposed device has different size specification to the predicate device, but all proposed devices are meet the specifications of ASTM D 6319.
So we consider this as the proposed device is same with the predicate device.
| Table 3 Performance Comparison | |
|---|---|
| -------------------------------- | -- |
| ITEM | Proposed Device
Medical Nitrile Examination Gloves
(Powder free, Blue) | Predicate Device (K150340)
POWDER FREE Nitrile GLOVES
(White, Cobalt Blue, Black, Ice
Blue) | Remark |
|----------|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------|
| Colorant | Blue | White, Cobalt Blue, Black, Ice Blue | Analysis 2 |
6
| Physical
Properties | | Tensile
Strength | 14 MPa, min | 15 MPa, min | Analysis 3 |
|------------------------|-----------------|------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------|------------|
| | Before
Aging | 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 |
| | | | Comply with ASTM D6319 | Comply with ASTM D6319 | SAME |
| Freedom from Holes | | | Be free from holes when tested in
accordance with ASTM D5151 | Be free from holes when tested in
accordance with ASTM D5151 | SAME |
| Powder Content | | | Less than 2 mg per glove when tested
in accordance with ASTM D6124 | Meet the requirements of ASTM
D6319 | SAME |
Analysis 2:
The proposed device has different color to the predicate device, this different may causes potential biocompatibility risk, for this risk we conducted the biocompatibility test according to the ISO 10993-10, the test results showed that the proposed devices with blue colorant did not induce skin irritation and showed no significant evidence of causing skin sensitization.
So we consider this as the proposed device is SE with the predicate device.
Analysis 3:
The proposed device has different Tensile Strength before aging specification to the predicate device, but all proposed device meets the specification requirements of ASTM D 6319.
So we consider this as the proposed device is SE with the predicatedevice.
| ITEM | | Proposed Device
Medical Nitrile Examination Gloves
(Powder free, Blue) | Predicate Device (K150340)
POWDER FREE Nitrile GLOVES
(White, Cobalt Blue, Black, Ice Blue) | Remark |
|--------------------|-------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|------------|
| | Material | Nitrile | Nitrile | SAME |
| Biocompatibility | Irritation | Under the conditions of the study
(ISO 10993-10), not an irritant | Under the conditions of the study,
not an irritant | SAME |
| | Sensitization | Under conditions of the study (ISO 10993-10), not a sensitizer. | Under conditions of the study, not
a sensitizer. | |
| | Acute
Systemic
Toxicity | Under the condition of the study
(ISO 10993-11), there is no mortality
or evidence of systemic toxicity | / | Analysis 4 |
| Label and Labeling | | Meet FDA's Requirements | Meet FDA's Requirements | SAME |
Table 4 Safety Comparison
Analysis 4
The proposed device has conducted the testing of Acute Systemic Toxicity which is the predicate device did not, the testing results shown that the proposed device has no systemic toxicity.
7
-
- Summary of Non-Clinical Performance Tests
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Summary of Non-Clinical Performance Tests
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves. ASTM D6124-17, Standard Test Method for Residual Powder on Medical Gloves. 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.