(341 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier protection of a glove, with no mention of AI or ML.
No.
The device description states it is a glove intended to prevent contamination, acting as a barrier, and does not mention any therapeutic function.
No
The device is described as a patient examination glove, whose principle operation is to provide "single use barrier protection for the wearer". There is no mention of it being used to diagnose conditions or processes.
No
The device is a physical examination glove made from thermoplastic elastomer, clearly described as a hardware product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the glove is "worn on the examiner's hand or fingers to prevent contamination between patient and examiner." This describes a physical barrier function, not a diagnostic test performed in vitro (outside of the body).
- Device Description: The description focuses on the materials and physical properties of the glove, emphasizing its role as a "single use barrier protection."
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (like blood, urine, tissue), detect biomarkers, or provide any kind of diagnostic information about a patient's health status.
- Regulatory Classification: The device is classified as Class I under 21 CFR 880.6250, which is the regulation for patient examination gloves. IVDs typically fall under different regulatory classifications depending on their risk level.
In summary, the device is a physical barrier intended for protection during patient examination, not a tool for performing diagnostic tests.
N/A
Intended Use / Indications for Use
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Thermoplastic Elastomer (TPE) Hybrid Examination Glove is a patient examination glove made from polyethylene resin and styrene-ethylene-styrene (SEBS) compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
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 (medical purpose)
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)
The following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device. Thermoplastic Elastomer (TPE) Hybrid Examination Glove made by Xuzhou Full Sun Medical Products Ltd. met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing:
Tests conducted:
- Dimension: ASTM D3767
- Freedom from holes (Water leak): 21 CFR 800.20 & ASTM D5151-19
- Tensile strength (Before aging/After aging): ASTM D412-16 & ASTM D573-04
- Elongation (Before aging/After aging): ASTM D412-16 & ASTM D573-04
- Powder Residual: ASTM D6124-06
- Biocompatibility - Skin Irritation: ISO 10993-10:2010
- Biocompatibility - Skin Sensitization: ISO 10993-10:2010
- Biocompatibility - cytotoxicity: ISO 10993-5:2009
All tests passed.
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 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".
January 23, 2022
Xuzhou Full Sun Medical Products Ltd. Elizabeth Deng U.S. Representative 5748 Eaglewood Place Rancho Cucamonga, California 91739
Re: K210463
Trade/Device Name: Thermoplastic Elastomer (TPE) Hybrid Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: December 20, 2021 Received: December 23, 2021
Dear Elizabeth Deng:
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 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
1
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 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).
Sincerely,
For 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210463
Device Name
Thermoplastic Elastomer (TPE) Hybrid Examination Glove
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand 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/0 description: The image shows the logo for Xuzhou Full Sun Medical Products LTD. The logo consists of the letters 'FS' in blue and green, with a green plus sign below the 'F'. To the right of the logo is the company name in Chinese, followed by the English translation 'XUZHOU FULL SUN MEDICAL PRODUCTS LTD.'
ounty. Jiangsu Province. 221316. China
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: K210463
0.0 Summary Preparation Date: Jan. 20th, 2022
1.0 Submitter:
| Submitter's name: | Xuzhou Full Sun Medical Products Ltd. |
|---|---|
| Submitter's address: | Bihe Industry Area, Yitang Town, Pizhou County |
| Jiangsu, China 221316 | |
| Phone number: | 86 - 516 - 67680555 |
| Fax number: | 86 - 516 - 67680098 |
| Name of contact person: | Hsun-Hui Huang |
Elizabeth Deng
909 4659188
5748 Eaglewood Place
Rancho Cucamonga, California Rancho Cucamonga, CA 91739
baxianunited48(@yahoo.com
2.0 US Agent:
US Representative Name: Company Address:
Telephone Number: Contact Email Address:
3.0 Name of the Device
Proprietary/Trade name:
Common Name: Classification Name: Device Classification: Regulation Number: Product Code:
Thermoplastic Elastomer (TPE) Hybrid Examination Glove Polymer Examination Gloves Non-powdered Patient Examination Glove Class I 21 CFR 880.6250 LZA
4.0 Predicate device
Device Name:
Company name: 510(K) Number: Disposable Powder Free Nitrile Examination Glove, Pink/Black Color Ever Growth (Vietnam) Co., Ltd. K190942
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Image /page/4/Picture/0 description: The image shows the logo for Xuzhou Full Sun Medical Products LTD. The logo consists of a stylized "FS" in blue and green, with a plus sign incorporated into the "S". To the right of the logo is the company name in both Chinese and English. The Chinese characters are larger and bolder than the English text.
Binhe Industry Area. nty, Jiangsu Province, 221316, Chi +86-516-67680090 · FAX :
5.0 Device Description:
Thermoplastic Elastomer (TPE) Hybrid Examination Glove is a patient examination glove made from polyethylene resin and styrene-ethylene-styrene (SEBS) compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
6.0 Device Indications for use:
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
| Device | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Characteristic | |||
| Product Name | Disposable Powder Free Nitrile | ||
| Examination Glove, Pink/Black | |||
| Color | Thermoplastic Elastomer (TPE) | ||
| Hybrid Examination Glove | N/A | ||
| 510(K) No. | K190942 | K210463 | N/A |
| Product Owner | Ever Growth (Vietnam) Co., Ltd. | Xuzhou Full Sun Medical | |
| Products Ltd. | N/A | ||
| Product Code | LZA | LZA | same |
| Regulation | 21 CFR 880.6250 | 21 CFR 880.6250 | same |
| Class | I | I | same |
| Indications for | |||
| Use | The Nitrile Powder Free patient | ||
| examination glove is a non- | |||
| sterile disposable device | |||
| intended for medical purposes | |||
| that is worn on the examiner's | |||
| hands or finger to prevent | |||
| contamination between patient | |||
| and examiner. | Thermoplastic Elastomer (TPE) | ||
| Hybrid Examination Glove is a | |||
| non-sterile disposable device | |||
| intended for medical purpose | |||
| that is worn on the examiner's | |||
| hands or fingers to prevent | |||
| contamination between patient | |||
| and examiner. | same | ||
| Power free | Yes | Yes | same |
| Size | X Small /Small/ | ||
| Medium/Large/X Large | Small/Medium/Large/X Large | similar | |
| Single Use | YES | YES | same |
| Non-Sterile | YES | YES | Same |
7.0 Comparison of device technological characteristics:
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Image /page/5/Picture/0 description: The image contains a logo for Xuzhou Full Sun Medical Products LTD. The logo consists of a blue and green graphic on the left, followed by the company name in Chinese characters and English. The English translation of the company name is "XUZHOU FULL SUN MEDICAL PRODUCTS LTD."
Binhe Industry Area, Yitang Town, Pizhou County, Jiangsu Province, 221316, China TEL:+86-516-67680090・FAX:+86-516-67680098
| Device | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Characteristic | |||
| Dimensions- | |||
| Length | Complies with ASTM D6319-10 | ||
| 230 mm min. | Complies with ASTM D6319-19 | ||
| 230 mm min. | same | ||
| Dimensions - | |||
| Palm Width | Complies with ASTM D6319 | ||
| X Small | |||
| 70 ± 10 mm | |||
| Small | |||
| 80 ± 10 mm | |||
| Medium | |||
| 95 ± 10 mm | |||
| Large | |||
| 110±10 mm | |||
| X large | |||
| 120 ±10 mm | Internal Standard | ||
| Small | |||
| 104 ± 5 mm | |||
| Medium | |||
| 107 ± 5 mm | |||
| Large | |||
| 115 ± 5 mm | |||
| X large | |||
| 123 ± 5 mm | Similar. Due | ||
| to the | |||
| characteristi | |||
| c of PE | |||
| material, we | |||
| use longer | |||
| dimension | |||
| for palm | |||
| width. | |||
| Dimensions - | |||
| Thickness | Complies with ASTM D6319 | ||
| Palm - 0.05 mm min. | |||
| Finger - 0.05 mm min. | Complies with ASTM D6319 | ||
| Palm - 0.05 mm min. | |||
| Finger - 0.05 mm min. | same | ||
| Physical | |||
| Properties | Tensile Strength | ||
| Before Aging: 14 MPa, min. | |||
| After Aging: 14 MPa, min. | Tensile Strength | ||
| Before Aging: 14 MPa, min. | |||
| After Aging: 14 MPa, min. | same | ||
| Elongation: | |||
| Before Aging: 500% min. | |||
| After Aging: 400% min. | Elongation: | ||
| Before Aging: 500% min. | |||
| After Aging: 400% min. | same | ||
| Residual | |||
| powder | Complies with ASTM D6319 | ||
| in vitro cytotoxicity | Pass |
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Image /page/7/Picture/0 description: The image displays the logo for Xuzhou Full Sun Medical Products LTD. The logo features a stylized "FS" in blue and green on the left. To the right of the emblem is the company name in Chinese characters, followed by the English translation "XUZHOU FULL SUN MEDICAL PRODUCTS LTD."
Binhe Industry Area, Yitang Town, Pizhou County, Jiangsu Province, 221316, China TEL:+86-516-67680090・FAX:+86-516-67680098
9.0 Assessment of Clinical Performance Data:
Clinical data is not needed for this type of device.
10.0 Conclusion:
The conclusion drawn from the nonclinical tests demonstrate that the subject device Thermoplastic Elastomer (TPE) Hybrid Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed device.