(94 days)
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No
The device, a nitrile examination glove, is intended to prevent contamination between patient and examiner, not to treat a disease or condition.
No
Explanation: The device is a nitrile examination glove, which is used to prevent contamination. It does not perform any diagnostic function.
No
The device is a physical glove made of nitrile, intended to be worn on the hands. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the device is a glove worn on the examiner's hands to prevent contamination. It is a physical barrier device.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples or provide any diagnostic information.
- Performance Studies: The performance studies focus on the physical properties of the glove (holes, powder, biocompatibility) and not on any diagnostic accuracy or analytical performance.
The device described is a medical device, specifically a medical glove, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Nitrile Examination 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.
Product codes
LZA
Device Description
The proposed device, Nitrile Examination Glove (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.
The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size. The color of the proposed device is Blue.
The proposed device is not provided as sterilized The proposed device is made of Nitrile.
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
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 verify that the proposed device met all design specifications found in the standards and test methods described below. 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
Performance Test Results Summary:
- ASTM D5151 (Testing for Freedom from holes): No water leakage is inspected form 125 samples
- ASTM D6124 (Determine the powder residue for powder free gloves): Residual Powder: Average 0. 1 Mg;
- ASTM D412, ASTM D573 (Testing for Physical property characteristics): Tensile Strength: >= 14 MPa; Ultimate Elongation: >= 400%.
- ASTM D3767 (Testing For physical dimensions specification): Length of Size S: >= 254 mm; Width of Size S: 88±1 (87-89) mm; Palm Thickness of Size XL: >=0.07 mm; Finger Thickness of Size XL: >=0.12 mm. Length of Size M: >= 251 mm; Width of Size M: 96±2 (95-98) mm; Palm Thickness of Size XL: >=0.07 mm; Finger Thickness of Size XL: >=0.12 mm. Length of Size L: >= 255 mm; Width of Size L: 110±1 (109-111) mm; Palm Thickness of Size XL: >=0.07 mm; Finger Thickness of Size XL: >=0.12 mm. Length of Size XL: >= 244mm; Width of Size XL: 113±2 (111-115) mm; Palm Thickness of Size XL: >=0.07 mm; Finger Thickness of Size XL: >=0.12 mm.
- ISO 10993-11 (Evaluate the endpoint of systemic toxicity for biocompatibility): Under the conditions of the study, the test article showed "negative" systemic toxicity.
- ISO 10993-10 (Evaluate the endpoint of irritant for biocompatibility): Under the experimental conditions, the test article has no skin irritation on rabbits.
- ISO 10993-10 (Evaluate the endpoint of sensitization for biocompatibility): The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig
No clinical study is included in this submission.
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
November 11, 2021
Jiangsu Jinlian Medical Technology Co., Ltd % Ray Wang General Manager Beijin Believe-Med Technology Service Co., Ltd Rm.912, Building#15, XiYueHui, No.5, YiHe North Rd. FangShan District Beigin, Beijing 102401 China
Re: K212497
Trade/Device Name: Nitrile Examination Glove (Powder free, Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 5, 2021 Received: August 9, 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 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Nitrile Examination Glove (Powder free, Blue)
Indications for Use (Describe)
The Nitrile Examination 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.
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 K212497
This 510(k) Summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
The assigned 510(k) Number: K212497
-
- Date of Preparation: 08/05/2021
-
- Sponsor
Jiangsu Jinlian Medical Technology Co., Ltd
No.14 Factory Building, 1st Floor, West of Century Avenue, Suqian Economic and Technological Development Zone, Suqian City, Jiangsu Province, China,223800 Contact Person: Wu Min Position: General Manager Tel: +86-18641219728 Fax: +86-527-82860533 Email: 247001296@qq.com
- Submission Correspondent 3.
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: ray.wang(@believe-med.com
-
- Proposed Device Identification
Trade Name: Nitrile Examination Glove (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
- Proposed Device Identification
4
Indication For Use Statement:
The Nitrile Examination 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.
-
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 -
Device Description 6.
The proposed device, Nitrile Examination Glove (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.
The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size. The color of the proposed device is Blue.
The proposed device is not provided as sterilized The proposed device is made of Nitrile.
| Size
Model | Cuff
Thickness
(mm) | Palm
Thickness
(mm) | Finger
Thickness
(mm) | Width
(mm) | Length
(mm) | Color |
|---------------|---------------------------|---------------------------|-----------------------------|---------------|----------------|-------|
| S | $\geq 0.05$ | $\geq 0.05$ | $\geq 0.05$ | 80±10 | | |
| M | $\geq 0.05$ | $\geq 0.05$ | $\geq 0.05$ | 95±10 | $\geq 230$ | Blue |
| L | $\geq 0.05$ | $\geq 0.05$ | $\geq 0.05$ | 110±10 | | |
| XL | $\geq 0.05$ | $\geq 0.05$ | $\geq 0.05$ | 120±10 | | |
Table 1 Device Size Specifications
Table 2 Performance and Physical Specifications
| Before Aging | After Aging | Pinhole AQL | ||
|---|---|---|---|---|
| Tensile Strength | Ultimate Elongation | Tensile Strength | Ultimate Elongation | 1.5 |
| 14 MPa, min | 500 % min | 14 MPa, min | 400 % min |
The above data of size, performance, and physical specifications of proposed gloves meet all the current specifications listed in the ASTM standard D6319.
5
7. Technological Characteristics Comparison Table
| ITEM | Proposed Device | Predicate Device (K150340) | Comparison |
|---|---|---|---|
| ITEM | Nitrile Examination Glove (Powder free, | ||
| Blue) | POWDER FREE Nitrile GLOVES (White, | ||
| Cobalt Blue, Black, Ice Blue) | SAME | ||
| Product Code | LZA | LZA | SAME |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | SAME |
| Class | I | I | SAME |
| Intended Use | The Nitrile Examination 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 POWDER FREE Nitrile GLOVES (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 | |||
| Powered free | Powdered free | Powdered free | SAME |
Table 1 General Comparison
6
| Proposed Device | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| Nitrile Examination Glove | |||||||
| (Powder free, Purple-Blue, | |||||||
| Blue) | Length, mm | 230 | 230 | 230 | 230 | min | |
| Width, mm | 80 | 95 | 110 | 120 | ±10 | ||
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Cuff | 0.05 | min | |||||
| Predicate Device (K150340) | Designation | XS | S | M | L | XL | Tolerance |
| POWDER FREE Nitrile | |||||||
| GLOVES (White, Cobalt Blue, | |||||||
| Black, Ice Blue) | 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 | |||||
| Remark | Analysis 1 |
Table 2 Device Dimensions Comparison
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
Nitrile Examination Glove
(Powder free, Blue) | Predicate Device (K150340)
POWDER FREE Nitrile GLOVES
(White, Cobalt Blue, Black, Ice Blue) | Comparison | |
|------------------------|-----------------|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------|------------|
| Colorant | | | Blue | White, Cobalt Blue, Black, Ice Blue | Analysis 2 |
| Physical
Properties | Before
Aging | Tensile
Strength | 14 MPa, min | 15 MPa, min | Analysis 3 |
| | | Ultimate
Elongation | 500 % min | 500 % min | SAME |
| | After
Aging | Tensile
Strength | 14 MPa, min | 14 MPa, min | SAME |
| | | Ultimate | 400 % min | 400 % min | SAME |
7
| Elongation | ||||
|---|---|---|---|---|
| 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 | |||
| 6319 | SAME |
Analysis 2:
The proposed device has different color to the predicate device
Analysis 3:
The proposed device has different Tensile Strength before aging specification to the predicate device
| ITEM | Proposed Device
Nitrile Examination Glove
(Powder free, Blue) | Predicate Device (K150340)
POWDER FREE Nitrile GLOVES
(White, Cobalt Blue, Black, Ice
Blue) | Comparison | |
|--------------------|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------|------|
| 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 |
| | Systemic
toxicity | Under conditions of the study, not a
systemic toxicity. | Under conditions of the study, not a
systemic toxicity. | SAME |
| Label and Labeling | Meet FDA's Requirements | Meet FDA's Requirements | SAME | |
Table 4 Safety Comparison
Summary of Non-Clinical Tests 8.
Bench tests were conducted to verify that the proposed device met all design specifications found in the standards and test methods described below. 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
8
Table 5 Performance Test Results Summary
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D5151 | Testing for Freedom | ||
| from holes | Freedom from holes | No water leakage is inspected form 125 | |
| samples | |||
| ASTM D6124 | Determine the powder | ||
| residue for powder free | |||
| gloves |