(85 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety of a medical glove, with no mention of AI or ML technologies.
No
The device is described as an exam glove intended to prevent contamination, not to treat or cure a disease or condition.
No
Explanation: The device is a medical glove intended for preventing contamination, not for diagnosing medical conditions.
No
The device description clearly states it is a "powder free medical glove," which is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An In Vitro Diagnostic device is a medical device that is used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Intended Use of the Device: The intended use of the Synguard Nitrile Exam Glove is clearly stated as "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier device used for protection and hygiene, not for performing diagnostic tests on patient samples.
- Device Description: The description details a standard medical glove, focusing on physical properties and compliance with standards for examination gloves. There is no mention of any components or functions related to analyzing biological samples.
- Lack of IVD-related information: The document does not contain any information typically associated with IVDs, such as:
- Mention of analyzing biological samples.
- Description of reagents or test procedures.
- Performance metrics like sensitivity, specificity, or AUC (which are relevant for diagnostic tests).
Therefore, based on the provided information, the Synguard Nitrile Exam Glove is a medical device, but it is not an In Vitro Diagnostic device. It falls under the category of a general medical device used for barrier protection.
N/A
Intended Use / Indications for Use
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.
Product codes
LZA
Device Description
The proposed device is a powder free medical glove. The device is blue in color. 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
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
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
Key Metrics
-Physical Dimensions:
- Width: S: 84 +/- 5mm, M: 94 +/- 5mm, L: 110 +/- 5mm, XL: 120 +/- 5mm (Pass)
- Length: S: 230mm, M: 230mm, L: 240mm, XL: 240mm (Pass)
- Thickness: Palm: 0.05mm min, Finger: 0.05mm min (Pass)
-Physical Properties (Before Aging): - Tensile Strength: 14MPa min (Pass)
- Ultimate Elongation: 500% min (Pass)
-Physical Properties (After Aging): - Tensile Strength: 14MPa min (Pass)
- Ultimate Elongation: 400% min (Pass)
-Freedom from Holes: Be free from holes when tested in accordance with ASTM D5151 (Pass)
-Powder free residue: Less than 2mg per glove (Pass)
-Irritation (ISO 10993-10:2010): The polar and nonpolar device extracts did not cause an irritation response in the animal model. (Pass)
-Sensitization (ISO 10993-10:2010): The polar and nonpolar device extracts did not cause a sensitizing response in the animal model. (Pass)
-System toxicity (ISO 10993-11:2009): The polar and nonpolar device extracts did not cause a systemic toxicity response in the animal model. (Pass)
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.
May 12, 2022
Tianjin Aoshang Outdoor Equipment Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd. P.O.box 120-119 Shanghai. 200120 China
Re: K220442
Trade/Device Name: Synguard Nitrile Exam Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: February 11, 2022 Received: February 16, 2022
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 (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,
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Synguard Nitrile Exam Glove
Indications for Use (Describe)
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.
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 is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K220442
-
- Date of Preparation: 02/11/2022
-
- Sponsor Identification
Tianjin Aoshang Outdoor Equipment Co., Ltd. C-1-106, No.23 Xiangtan Road, Hongqiao District, Tianjin
Contact Person: Xiaoning Zhang Position: QS Engineer Tel: +86-22-87702678 Fax: +86-22-87702677 Email: zhangning860222@163.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (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
4. Identification of Proposed Device
Trade Name: Synguard Nitrile Exam Glove Common Name: POWDER FREE NITRILE EXAMINATION GLOVES
Regulatory Information
Classification Name: polymer patient examination glove
4
Classification: I; Product Code: LZA; Regulation Number: 21CFR 880.6250 Review Panel: General Hospital;
Indication for Use:
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.
Device Description
The proposed device is a powder free medical glove. The device is blue in color. 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.
- ડ. Identification of Predicate Device
510(k) Number: K172015
Product Name: Powder Free Nitrile Examination Gloves, Blue (colored)
5
6. Technological Characteristics Comparison
| ITEM | Subject Device
K220442 | Predicate Device
K172015 | Comparison | | |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|------------|-----------|
| Product Code | LZA | LZA | Same | | |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | | |
| Class | I | I | Same | | |
| Indication for use | 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. | A 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. | Same | | |
| Material | Acrylonitrile, Butadiene | Nitrile | Different | | |
| Color | Blue | Blue | Same | | |
| Sterility | Non-sterile | Non-sterile | Same | | |
| Single-use | Yes | Yes | Same | | |
| Size | S, M, L, XL | XS, S, M, L, XL | | | |
| | Width | | | | |
| | / | XS | $70\pm10mm$ | | |
| | S | $84\pm5mm$ | $80\pm10mm$ | | |
| | M | $94\pm5mm$ | $95\pm10mm$ | | |
| | L | $110\pm5mm$ | $110\pm10mm$ | | |
| | XL | $120\pm5mm$ | $120\pm10mm$ | | |
| | Length | | | | |
| Dimensions
(ASTM D6319-19) | / | XS | 220mm min | Different | |
| | S | 230mm | 220mm min | | |
| | M | 230mm | 230mm min | | |
| | L | 240mm | 230mm min | | |
| | XL | 240mm | 230mm min | | |
| | Thickness | | | | |
| | Palm | 0.05mm min | Palm | 0.05mm min | |
| | Finger | 0.05mm min | Finger | 0.05mm min | |
| | Before Aging | | | | |
| Physical Properties
(ASTM D6319-19
and ASTM
D412-16) | Tensile Strength | 14MPa min | Tensile Strength | 14MPa min | Same |
| | Ultimate Elongation | 500% min | Ultimate Elongation | 500% min | |
| | After Aging | | | | |
| | Tensile Strength | 14MPa min | Tensile Strength | 14MPa min | |
| | Ultimate Elongation | 400% min | Ultimate Elongation | 400% min | |
| Power 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. | | Before aging: Meet AQL 1.5
After aging: Meet AQL 2.5 | | Different |
| Biocompatibility | | | | | |
| Skin Irritation | No Irritation | | No Irritation | | |
| Sensitization | No Sensitization | | No Sensitization | | Different |
| Systemic Toxicity | No Toxicity | | / | | |
Table 1 Comparison of Technology Characteristics
Page 3 of 6
6
Different- Material
The material of the proposed device is different from predicate device.
Different- Size& Dimensions
The size and dimension of the proposed device is not exactly same as the predicate device.
Different- Freedom from Holes
The performance description of freedom from holes of the proposed device is different from predicate device.
Different- Biocompatibility
The biocompatibility test item of the proposed device is different from the predicate device.
7. Non-Clinical Test Conclusion
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;
7
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 | 84±5mm | Pass |
| | | | M | 94±5mm | |
| | | | L | 110±5mm | |
| | | | XL | 120±5mm | |
| | | Length | S | 230mm | |
| | | | M | 230mm | |
| | | | L | 240mm | |
| | | | XL | 240mm | |
| | | Thickness | Palm | 0.05mm min | |
| | | | Finger | 0.05mm min | |
| ASTM D6319-19,
ASTM D412-16 | Physical Properties | Before Aging | Tensile
Strength | 14MPa min | Pass |
| | | | Ultimate
Elongation | 500% min | |
| | | After Aging | Tensile
Strength | 14MPa min | |
| | | | Ultimate | 400% min | |
Table 2 Summary of non-clinical performance testing
8
| Elongation | |||
|---|---|---|---|
| ASTM D5151-19 | Freedom from | ||
| Holes | Be free from holes when tested in accordance | ||
| with ASTM D5151 | Pass | ||
| ASTM D6124-06 | Powder free residue | Less than 2mg per glove | Pass |
| ISO 10993-10:2010 | Irritation | The polar and nonpolar device extracts did not | |
| cause an irritation response in the animal | |||
| model. | Pass | ||
| ISO 10993-10:2010 | Sensitization | The polar and nonpolar device extracts did not | |
| cause a sensitizing response in the animal | |||
| model. | Pass | ||
| ISO 10993-11:2009 | System toxicity | The polar and nonpolar device extracts did not | |
| cause a systemic toxicity response in the | |||
| animal model. | Pass |
8. Clinical Test Conclusion
No clinical study is included in this submission.
9. 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 K172015.