(88 days)
Not Found
No
The device is a simple examination glove and the description focuses on material properties and standard compliance, with no mention of AI or ML.
No.
The device (gloves) is intended to prevent contamination, not to treat a disease or condition.
No
The device description clearly states "Medical Nitrile Examination Gloves 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." This indicates its purpose is for barrier protection, not for diagnosing medical conditions.
No
The device description clearly states it is a physical product (gloves) and describes material properties, sizes, and physical standards it meets. There is no mention of software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that the device 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." This is a barrier device used on the body, not a device used to test samples from the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples.
- Detection or measurement of substances in samples.
- Providing diagnostic information based on test results.
- Reagents or test kits.
The device described is a medical glove, which is a Class I or Class II medical device depending on its intended use and risk, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Medical nitrile examination gloves 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
The proposed device, Medical Nitrile Examination Gloves, is a powder free patient examination glove, it is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner. The device is provided in blue, purple, white and black colors. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The proposed gloves are available in four sizes, which are S, M, L, XL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The proposed device is provided in non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand or finger
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 performance of the proposed device met all design specifications of the applicable and current standards. 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 D3767-03 (2020) Standard Practice for Rubber-Measurement of Dimensions
- ASTM D412-16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
- ASTM D6124-06 (Reapproved 2017) 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;
The test results show:
- Physical Dimensions: Width (S: 80±10mm, M: 95±10mm, L: 110±10mm, XL: 120±10mm); Length (S: 220mm min, M: 230mm min, L: 230mm min, XL: 230mm min); Thickness (Palm: 0.05mm min, Finger: 0.05mm min). All results Pass.
- Physical Properties: Before Aging - Tensile Strength (14MPa min), Ultimate Elongation (500% min); After Aging - Tensile Strength (14MPa min), Ultimate Elongation (400% min). All results Pass.
- Freedom from Holes: No water leakage occurs. AQL2.5. Result Pass.
- Powder free residue: Less than 2mg per glove. Result Pass.
- Irritation: Non-Irritating. Result Pass.
- Sensitization: Non-Sensitizing. Result Pass.
- Acute Systemic toxicity: Non-toxicity. Result 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 contains 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.
November 21, 2023
Jiangsu Complete Sincerity Medical New Materials Co., Ltd. % Diana Hong General Manger Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China
Re: K232576
Trade/Device Name: 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: August 10, 2023 Received: August 25, 2023
Dear Diana Hong:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232576
Device Name Medical nitrile examination gloves
Indications for Use (Describe)
Medical nitrile examination gloves 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.
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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4
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K232576
- Date of Preparation: 10/20/2023 1.
-
- Sponsor Identification
Jiangsu Complete Sincerity Medical New Materials Co., Ltd.
NO.7 Wenzhou Road, Economic Development Zone, Shuyang County, Suqian, Jiangsu Province, China, 223600
Contact Person: Shangjun Xie Position: General Manager Tel: +86-527-81229099 Email: 392421042@qq.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Xingqi Wang (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-2281-5850, Fax: 360-925-3199 Email: info@mid-link.net
-
- Identification of Proposed Device
Trade Name: Medical Nitrile Examination Gloves Common Name: Medical Nitrile Examination Gloves
- Identification of Proposed Device
Regulatory Information
5
Classification Name: Non-powdered patient examination glove Classification: I Product Code: LZA; Regulation Number: 21CFR 880.6250 Review Panel: General Hospital
Indications for use:
Medical nitrile examination gloves 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.
Device Description
The proposed device, Medical Nitrile Examination Gloves, is a powder free patient examination glove, it is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner. The device is provided in blue, purple, white and black colors. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The proposed gloves are available in four sizes, which are S, M, L, XL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The proposed device is provided in non-sterile.
న్. Identification of Predicate Device
510(k) Number: K220442 Product Name: Synguard Nitrile Exam Glove Manufacturer: Tianjin Aoshang Outdoor Equipment Co., Ltd.
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6. Technological Characteristics Comparison
Table 1 Comparison of Technology Characteristics
| ITEM | Proposed Device | Predicate Device K220442 | Remark |
|---|---|---|---|
| Product Code | LZA | LZA | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Indication for use | Medical nitrile examination gloves 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. | Synguard Nitrile Exam 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. | Same |
| Material | NATEX CNBR LATEX | Acrylonitrile, Butadiene | Different |
| 1 | |||
| Color | Blue, White, Black, Purple | Blue | Different |
| 2 | |||
| Sterility | Non-sterile | Non-sterile | Same |
| Single-use | Yes | Yes | Same |
| Size | S, M, L, XL | S, M, L, XL | |
| Dimensions | |||
| (ASTM D6319-19) | Width | Different | |
| 3 | |||
| S | $80 \pm 10mm$ | ||
| M | $95 \pm 10mm$ | ||
| L | $110 \pm 10mm$ | ||
| XL | $120 \pm 10mm$ | ||
| Length | |||
| S | 220mm min | ||
| M | 230mm min | ||
| L | 230mm min | ||
| XL | 230mm min | ||
| Thickness | |||
| Palm | 0.05mm min | ||
| Finger | 0.05mm min | ||
| Physical Properties | |||
| (ASTM D6319-19 | |||
| and ASTM | |||
| D412-16) | Before Aging | Same | |
| Tensile Strength | 14MPa min | ||
| Ultimate Elongation | 500% min |
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| Tensile Strength | 14MPa min | Tensile Strength | 14MPa min | ||
|---|---|---|---|---|---|
| Ultimate | |||||
| Elongation | 400% min | Ultimate Elongation | 400% min | ||
| Powder free residue | |||||
| (ASTM D6319-19 | |||||
| and ASTM | |||||
| D6124-06) | Less than 2mg per glove | Less than 2mg per glove | Same | ||
| Freedom from | |||||
| Holes (ASTM | |||||
| D5151-19) | No water leakage occurs. AQL2.5 | No water leakage occurs. AQL2.5 | Same | ||
| Biocompatibility | |||||
| Skin Irritation | No Irritation | No Irritation | |||
| Sensitization | No Sensitization | No Sensitization | Same | ||
| Acute System | |||||
| Toxicity | No Acute Systemic Toxicity | No Acute Systemic Toxicity |
Different 1- Material
The material of the proposed device is different from the predicate device. However, the biocompatibility and specification performance tests have been performed on each of the proposed devices and the test results show no significant concerns. The difference will not affect the safety and effectiveness of the proposed device.
Different 2- Color
The color of the proposed device is different from the predicate device. However, the biocompatibility and specification performance tests have been performed on each of the proposed devices and the test results show no significant concerns. Therefore, the difference will not affect the safety and effectiveness of the proposed device.
Different 3- Size& Dimensions
The size and dimension of the proposed device is not exactly same as the predicate device. However, the size and dimension of the proposed device has been covered by ASTM D6319-19. The user can select appropriate model depended on size of user's hand. In addition, its dimension has been tested and met the requirement of ASTM D6319-19. Therefore, the difference will not affect the safety and effectiveness of the proposed device.
7. Summary of Non-Clinical Testing
Non clinical tests were conducted to verify that the performance of the proposed device met all design specifications of the applicable and current standards. The test results demonstrated that the proposed device complies with the following standards:
8
-
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 D3767-03 (2020) Standard Practice for Rubber-Measurement of Dimensions
-
ASTM D412-16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
-
ASTM D6124-06 (Reapproved 2017) 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;
| Test Methodology | Purpose | Acceptance Criteria | | Results
(Pass/Fail) |
|-------------------------------------------|------------------------|-----------------------------------------------------------------|-----------------------------------------------|--------------------------------------------------|
| ASTM D6319-19,
ASTM D3767-03
(2020) | Physical
Dimensions | Width | S
M
L
XL | 80±10mm
95±10mm
110±10mm
120±10mm |
| | | Length | S
M
L
XL | 220mm min
230mm min
230mm min
230mm min |
| | | Thickness | Palm
Finger | 0.05mm min
0.05mm min |
| ASTM D6319-19,
ASTM D412-16 | Physical Properties | Before Aging | Tensile
Strength
Ultimate
Elongation | 14MPa min
500% min |
| | | After Aging | Tensile
Strength
Ultimate
Elongation | 14MPa min
400% min |
| | | | | |
| ASTM D5151-19 | Freedom from
Holes | Be free from holes when tested in accordance with
ASTM D5151 | | |
| ASTM D6124-06 | Powder free residue | Less than 2mg per glove | | |
| ISO 10993-10:2010 | Irritation | Non-Irritating | | |
Table 2 Summary of non-clinical performance testing
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| ISO 10993-10:2010 | Sensitization | Non-Sensitizing | Pass |
|---|---|---|---|
| ISO 10993-11:2009 | Acute Systemic | ||
| toxicity | Non-toxicity | Pass |
8. Summary of Clinical Testing
No clinical study is included in this submission.
-
- Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the proposed subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K220442.
- Conclusion: