(87 days)
Not Found
No
The device description and performance studies focus on material properties and compliance with standards for physical characteristics and biocompatibility, with no mention of AI or ML.
No
The device, a disposable vinyl glove, is intended for preventing contamination between patient and examiner, not for treating or rehabilitating a medical condition.
No
The device is a disposable vinyl glove, intended for preventing contamination, not for diagnosing any medical condition.
No
The device description clearly states it is a physical product (gloves) and the testing described relates to physical properties and biocompatibility, not software performance.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on the examiner's hands to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function performed on samples taken from the body.
- Device Description: The description focuses on the physical characteristics and standards related to the glove's material and integrity. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of Diagnostic Function: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This glove does not perform any such analysis.
- Relevant Standards: The standards mentioned (ASTM D6124, ASTM D5151, ASTM D5250) are related to the physical properties and integrity of examination gloves, not to diagnostic testing.
- No Mention of Diagnostic Data: The document does not discuss any diagnostic data, metrics (like sensitivity, specificity), or performance studies related to analyzing biological samples.
This device is a medical device used for barrier protection during medical examinations, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Disposable Vinyl Glove is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Product codes
LYZ
Device Description
The subject device is powder free vinyl patient examination gloves. The subject device is clear, non-colored. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
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 / Not Found
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 proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards: ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves ASTMD5151-06(Reapproved2015), Standard Test Method for Detection of Holes in Medical Gloves. ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application. Clinical testing is not needed for this device.
Key Metrics
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.
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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.
October 16, 2020
Better Health Medical Products Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. Room608,No.738,Shangcheng Rd.,Pudong Shanghai, 200120 Cn
Re: K202010
Trade/Device Name: Disposable Vinyl Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: June 15, 2020 Received: July 21, 2020
Dear Boyle 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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: CAPT Elizabeth Claverie, M.S. 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
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Indications for Use
510(k) Number (if known) K202010
Device Name Disposable Vinyl Glove
Indications for Use (Describe)
The Disposable Vinyl Glove is 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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510(k) Summary K202010
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Better Health Medical Products Co., Ltd. Address: Zhangliu Road, Zhangdian District, 255087 Zibo City, Shandong, China. Phone Number: +86-533-3819144 Contact: Mr. Xiaomeng Li Date of Preparation: 6/15/2020
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Disposable Vinyl Gloves Common name: Vinyl Patient Examination Glove Classification name: Non-powdered Patient Examination Glove Model(s): XS, S. M. L. XL
3.0 Classification
Production code: LYZ Requlation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate Device Information
Hebei Hongtai Plastic Products Company Limited Manufacturer: Vinyl Patient Examination Gloves (White, Blue, Yellow) Device: 510(k) number: K163168
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5.0 Indication for Use
The Disposable Vinyl Glove is intended for medical purposes that is worn on the examiners hands to prevent contamination between patient and examiner.
6.0 Device Description
The subject device is powder free vinyl patient examination gloves. The subject device is clear, non-colored. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
7.0 Technological Characteristic Comparison Table
| Table1-General Comparison | |||
|---|---|---|---|
| Item | Subject device | Predicated device | Comparison |
| 510(k) number | K202010 | K163168 | Different |
| Product Code | LYZ | LYZ | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Disposable Vinyl Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. | The Vinyl Examination Glove (White, Blue, or Yellow) 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 |
| Design | |||
| Feature | Ambidextrous | Ambidextrous | Same |
| Labeling | |||
| Information | Single use, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile | Single use, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile | Similar |
Table1-General Comparison
| Table2 Device Dimensions Comparison | ||
|---|---|---|
| ------------------------------------- | -- | -- |
| Predicate | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| Device(K163168) | XS | S | M | L | XL | ||
| Length, mm | 230 | 230 | 235 | 245 | 245 | min | |
| Width, mm | 80 | 85 | 95 | 105 | 115 | $\pm 5$ | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.08 | min |
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| Subject Device | Designation | Size | Tolerance | ||
|---|---|---|---|---|---|
| XS | S | M | |||
| Length, mm | 240 | 240 | 240 | min | |
| Width, mm | 80 | 85 | 95 | $\pm 5$ | |
| Thickness, mm: | |||||
| Finger | 0.05 | min | |||
| Palm | 0.08 | min | |||
| Comparison | Similar |
Table3 Performance Comparison
| Item | Subject device | Predicated device | Comparison | |
|---|---|---|---|---|
| Colorant | Clear, Non-Colored | White, Blue, Yellow | Different | |
| Physical | ||||
| Properties | Before Aging Tensile Strength | 14MPa, min | 15MPa, min | Similar |
| Ultimate Elongation | 500%min | 380%min | Similar | |
| After Aging Tensile Strength | 14MPa, min | 15MPa, min | Similar | |
| Ultimate Elongation | 400%min | 380%min | Similar | |
| Comply with ASTM D5250 | Comply with ASTM D5250 | Comply with ASTM D5250 | Same | |
| Freedom from Holes | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | Same | |
| Powder Content |