(88 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a standard examination glove, with no mention of AI or ML capabilities.
No.
A therapeutic device is one that treats or heals a disease or condition. This device is a glove, intended for barrier protection, not treatment.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. It does not provide any diagnostic information.
No
The device is a physical patient examination glove made of nitrile latex, not software.
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 a "disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner." This describes a barrier device used for infection control during physical examinations.
- Device Description: The description details a physical glove made of synthetic nitrile latex.
- Performance Studies: The performance studies focus on the physical properties of the glove (tensile strength, elongation, freedom from holes, residual powder) and biocompatibility (skin sensitization, intracutaneous reactivity, acute systemic toxicity). These are tests related to the physical integrity and safety of a barrier device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. There is no mention of reagents, assays, or any other components typically associated with IVD devices.
IVD devices are specifically designed to perform tests on biological samples outside the body to gain diagnostic or other medical information. This device is a physical barrier used on the body during an examination.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
The subject device is a patient examination glove made of synthetic nitrile latex compound. It is Non-Sterile, Powder free and is Blue in color. The device is ambidextrous and can be worn on either the left or right hand. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-11.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or fingers
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)
Non-Clinical Testing:
Biocompatibility:
- ISO 10993-10: Skin Sensitization test
- ISO 10993-10: Intracutaneous Reactivity test
- ISO 10993-11: Acute Systemic Toxicity test
Performance Testing: Physical performance testing was conducted as per ASTM D6319-19, ASTM D6124-06 (Reapproved 2017), and ASTM D5151-19.
Key results: - Dimensions (length, width, thickness): Passed.
- Physical properties (Tensile Strength, Elongation before and after aging): Passed.
- Freedom from holes: Passed (No leakage; 312 of 315 passed).
- Residual Powder: Passed (average 0.17 mg per glove).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Length: Pass 240 mm min
- Width:
- XS: average 78.3mm
- S: average 86.5mm
- M: average 97.6mm
- L: average 108.7mm
- XL: average 115.4mm
- XXL: average 123.7mm
- Thickness:
- Palm 0.06mm min.
- Finger - 0.082mm min
- Physical properties:
- Before Aging: Tensile Strength: 22.6MPa, min.; Elongation: 531%, min.
- After Aging: Tensile Strength: 21.9MPa, min.; Elongation: 437%, min.
- Freedom from holes: No leakage, 312 of 315 passed
- Residual Powder: average 0.17 mg per glove
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.
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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 and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 11, 2023
Shandong Intco Medical Products Co, Ltd. % Deze Wang Official Correspondent Intco Medical Industries, Inc 805 Barrington Ave. Ontario, California 91764
Re: K231408
Trade/Device Name: Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: May 11, 2023 Received: May 15, 2023
Dear Deze 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,
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) K231408
Device Name
Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers 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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Image /page/3/Picture/2 description: The image shows the logo for INTCO Medical. The logo features the company name in blue, with the letters "INTCO" in a bold, sans-serif font. Below the company name are the Chinese characters "英科 医疗", also in blue. Above the company name is a stylized blue graphic that resembles a flower or sunburst, with several petal-like shapes radiating from a central point.
510(K) Summary
(As requirement by 21 CFR 807.92)
Date : A. Applicant: Name: Shandong Intco Medical Products Co., Ltd. Address: Qiwang Road, Naoshan Industrial Park, Qingzhou, Shandong, China Contact: Ms. Min Gao Title: QA Tel: +86-536-6136888 Email: gaomin@intco.com
Submission Correspondent: Primary contact: Max Li Shandong Intco Medical Products Co., Ltd. Qiwang Road, Naoshan Industrial Park, Qingzhou, Shandong, China Tel: +86-536-6136888 Email: maxli@intco.com Secondary contact: Min Gao Qiwang Road, Naoshan Industrial Park, Qingzhou, Shandong, China Tel: +86-536-6136888 Email: gaomin@intco.com
B. Device:
Trade Name: Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile. Common Name: Non-Powdered Patient Examination Glove
Regulatory Information Classification Name: Non-Powdered Patient Examination Glove Classification: Class I Product code: LZA Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital and Personal Use
C. Predicate device:
K221169 Name of the device: Nitrile Examination Gloves Powder Free-Black Owner's Name: JR Engineering & Medical Technologies (M) Sdn. Bhd. Classification: Class I Product code: LZA Regulation Number: 21 CFR 880.6250
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D. Indications for use of the device:
The Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile is a disposable device intended for medical purposes that is worn on the examiners' hand or fingers to prevent contamination between patient and examiner.
E. Device Description:
The subject device is a patient examination glove made of synthetic nitrile latex compound. It is Non-Sterile, Powder free and is Blue in color. The device is ambidextrous and can be worn on either the left or right hand. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-11.
F. Summary of Technological Characteristics
The Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile are compared with the predicate device in terms of intended use, design, material, specifications, and performance. The following table shows similarities and differences of use, design, and material between the proposed device and the predicate device.
| Device | Proposed Device | Predicate Device | Result | |
|---|---|---|---|---|
| 510K # | K231408 | K221169 | - | |
| Product Name | Basic Synguard Nitrile Exam Gloves, | |||
| Powder Free, Blue Colored, Non- | ||||
| Sterile | JR MEDIC Nitrile Examination Gloves | |||
| Powder Free- Black | - | |||
| Manufacturer(s) | Shandong Intco Medical Products Co., | |||
| Ltd. | JR Engineering & Medical | |||
| Technologies (M) SDN.BHD. | - | |||
| Product Code | LZA | LZA | Same | |
| Regulation | ||||
| Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | |
| Indications for | ||||
| use | The Basic Synguard Nitrile Exam | |||
| Gloves, Powder Free, Blue Colored, | ||||
| Non-Sterile is a disposable device | ||||
| intended for medical purposes that is | ||||
| worn on the examiners' hand or finger | ||||
| to prevent contamination between | ||||
| patient and examiner. | Nitrile Examination Gloves Powder | |||
| free is a disposable device intended | ||||
| for medical purpose that is worn on | ||||
| the examiner's hand to prevent | ||||
| contamination between patient and | ||||
| examiner. | Same | |||
| Powder free | Yes | Yes | Same | |
| Design feature | Ambidextrous. | Ambidextrous. | Same | |
| Material | Nitrile | Nitrile | Same | |
| Color | Blue | Black | Different | |
| Size | XS, S, M, L, XL, XXL | XS, S, M, L, XL | Similar | |
| Sterile | Non-Sterile | Non-Sterile | Same | |
| Use | Singe use | Single use | Same | |
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | Remarks | |
| SUBJECT | PREDICATE | |||
| 510(k) Number | K231408 | K221169 | ---- | |
| Name of device | Basic Synguard Nitrile | |||
| Exam Gloves, Powder | ||||
| Free, Blue Colored, Non- | ||||
| Sterile | Nitrile Examination | |||
| Gloves Powder Free- | ||||
| Black | ---- | |||
| Dimensions | ASTMD6319- 19 | Length Min 230 m | ||
| Width Min 95+/- 10 mm | ||||
| ( for medium size) | Length Min 230 mm | |||
| Width Min 95+/- 10 | ||||
| mm | ||||
| (for medium size) | Same | |||
| Physical Properties | ASTMD6319- 19 | Before Aging | ||
| Tensile Strength | ||||
| min 14 MPa | ||||
| Ultimate Elongation | ||||
| Min 500% | ||||
| After Aging | ||||
| Tensile Strength | ||||
| min 14 MPa | ||||
| Ultimate Elongation | ||||
| Min 400% | Before Aging | |||
| Tensile Strength | ||||
| min 14 MPa | ||||
| Ultimate Elongation | ||||
| Min 500% | ||||
| After Aging | ||||
| Tensile Strength | ||||
| min 14 MPa | ||||
| Ultimate Elongation | ||||
| Min 400% | Same | |||
| Thickness | ASTMD6319- 19 | Palm min 0.05 mm | ||
| Finger min 0.05 mm | Palm min 0.05 mm | |||
| Finger min 0.05 mm | Same | |||
| Powder Free | ASTMD6319- 19 | ≤2 mg/glove | ≤2 mg/glove | Similar |
| Water leak | ASTM D5151-19 | 3/315 AQL2.5 | Meets ASTM | |
| D6319 requirements | Similar | |||
| Biocompatibility | Primary Skin | |||
| Irritation-ISO | ||||
| 10993-10:2010 |
Dermal
Sensitization- ISO
10993- 10:2010 | Under the condition of
study not an irritant
Under the conditions of
the study not a sensitizer | Under the condition
of study not an
irritant
Under the conditions of
the study not a sensitizer | Same |
| In vitro cytotoxicity
ISO10993-5 :2009 | Data Not available | Under the conditions
of the study, cytotoxic. | -------- | |
| Acute Systemic
Toxicity Test ISO
10993- 11:2017 | Under the conditions of this
study, there was no evidence
of systemic toxicity. | Under the condition of
study the device extracts
do not pose a systemic
toxicity. | Same | |
Table 1 General Comparison of Proposed and Predicate Devices
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Analysis: The proposed device has product size XS, S, M, L, XL, XXL . while the predicate device has product size XS, S, M, L, XL. The proposed device is Blue color, while the predicate device is black color. But safety and performance testing has been done to the proposed device and the results showed that the device meets the requirements of standard ASTM D6319-19. Therefore, this difference do not raise any new safety or performance questions.
Table 2 Comparison of Physical, Biocompatibility and Performance Testing
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Analysis: The proposed device has the Skin Sensitization test, Primary Skin Irritation test and the Acute Systemic Toxicity test. The result is the same as the PREDICATE device's.
G. Summary of Non-Clinical Testing
A Biocompatibility
The following tests for the subject device were conducted to evaluate the biocompatibility of Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile:
- ISO 10993-10: Skin Sensitization test
- ISO 10993-10: Intracutaneous Reactivity test
- ISO 10993-11: Acute Systemic Toxicity test
A Performance Testing
Physical performance testing of the proposed device was conducted as per ASTM D6319-19 Standard Specification for Nitrile Examination Gloves.
To summarize, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
• ASTM D6319-19 Standard Specification for Nitrile Examination Gloves.
- 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
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Dimensions (length) | |||
| (width) | |||
| (thickness) | The purpose of the | ||
| test is to evaluate | |||
| the physical | |||
| dimension of the | |||
| glove | Length | ||
| 230 mm min | Pass | ||
| 240 mm min | |||
| Width(mm) | Pass | ||
| XS: 70±10 | XS: average 78.3mm | ||
| S: 80±10 | S: average 86.5mm | ||
| M: 95±10 | M: average 97.6mm | ||
| L: 110±10 | L: average 108.7mm | ||
| XL: 120±10 | XL: average 115.4mm | ||
| XXL: 130±10 | XXL: average 123.7mm | ||
| Thickness(mm): | |||
| Palm: Minimum 0.05 | Pass | ||
| Palm 0.06mm min. |
7
| Finger: Minimum 0.05 | Finger - 0.082mm min | |||
|---|---|---|---|---|
| Physical properties | The purpose of the | |||
| test is to evaluate | ||||
| the tensile strength | ||||
| and ultimate | ||||
| elongation before | ||||
| and after aging | Before Aging: | |||
| Tensile Strength: 14 MPa, min. | ||||
| Elongation: 500%, min. | ||||
| After Aging: | ||||
| Tensile Strength: 14 MPa, min. | ||||
| Elongation: 400%, min. | Pass | |||
| Before Aging: | ||||
| Tensile Strength: 22.6MPa, min. | ||||
| Elongation: 531%, min. | ||||
| After Aging: | ||||
| Tensile Strength: 21.9MPa, min. | ||||
| Elongation: 437%, min. | ||||
| Freedom from holes | The purpose of the | |||
| test is to detect | ||||
| holes in the gloves | No leakage at sampling level of | |||
| G-1, AQL 2.5 | Pass | |||
| No leakage, 312 of 315 passed | ||||
| Residual Powder | The purpose of the | |||
| test is to detect the | ||||
| powder residue in | ||||
| the glove |