(95 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety of examination gloves, with no mention of AI or ML.
No
The device, disposable vinyl examination gloves, is intended to prevent contamination, not to treat or cure a disease or condition.
No
Explanation: The device is described as "Disposable Vinyl Examination Gloves" intended to prevent contamination. There is no mention of it being used to diagnose conditions or process diagnostic information.
No
The device is described as physical examination gloves, which are a hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This includes tests for diagnosis, monitoring, screening, and prognosis.
- Device Description: The description clearly states the device is a "Disposable Vinyl Examination Glove" worn on the hands.
- Intended Use: The intended use is to "prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on a specimen.
- Lack of Diagnostic Function: There is no mention of analyzing biological samples, detecting biomarkers, or providing any diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the physical properties of the glove (tensile strength, freedom from holes) and biocompatibility (irritation, sensitization, cytotoxicity), which are relevant for a barrier device, not a diagnostic test.
Therefore, based on the provided information, the Disposable Vinyl Examination Glove is a medical device, but it falls under the category of a Class I or Class II medical device (depending on the specific regulations and risk classification) used for barrier protection, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Disposable Vinyl Examination Gloves are intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 D5250-06, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
Clinical testing is not needed for this device.
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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 26, 2021
Shandong Zhushi Pharmaceutical Group Co., Ltd % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room608, No.738,Shangcheng Rd., Pudong Shanghai, 200120 China
Re: K203439
Trade/Device Name: Disposable Vinyl Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LYZ Dated: November 5, 2020 Received: November 23, 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.
1
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 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 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.
For Ryan Ortega, PhD Acting 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) K203439
Device Name Disposable Vinyl Examination Gloves
Indications for Use (Describe)
The Disposable Vinyl Examination Gloves are 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 (K203439)
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
Name: Shandong Zhushi Pharmaceutical Group Co., Ltd Address: No.6 Shande Road, Shan County, Heze City, Shandong, China Phone Number: +86-15764021131 Contact: Junhui Zhu Date of Preparation: 03/11/2020
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 Examination Gloves Common name: Non-powdered Patient Examination Glove Classification name: Vinyl Patient Examination Glove Model(s): XS, S, M, L, XL
3.0 Classification
Production code: LYZ Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate device information
Manufacturer: Hebei Hongtai Plastic Products Company Limited Device: Vinyl Patient Examination Gloves (White, Blue, Yellow) 510(k) number: K163168
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5.0 Indication for Use
The Disposable Vinyl Examination Gloves are 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 Characteristics
| Item | Subject device | Predicated device | Comparison |
|---|---|---|---|
| 510(k) number | K203439 | K163168 | / |
| Product Code | LYZ | LYZ | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | / | / | Same |
| Intended Use | The Disposable Vinyl | ||
| Examination Gloves are 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 | ||
| Sterility | Non-Sterile | Non-Sterile | Same |
Table1-General Comparison
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| 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 | ±5 | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.08 | min | |||||
| Subject Device | Designation | Size | Tolerance | ||||
| XS | S | M | L | XL | |||
| Length, mm | 220 | 220 | 230 | 230 | 230 | min | |
| Width, mm | 70 | 80 | 90 | 100 | 110 | ±5 | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.08 | min | |||||
| Remark | SAME |
Table2 Device Dimensions Comparison
Table3 Performance Comparison
| Item | Subject device | Predicated device | Comparison | ||
|---|---|---|---|---|---|
| Colorant | Clear, Non-Colored | White, Blue, Yellow | Analysis1 | ||
| Physical | |||||
| Properties | Before | ||||
| Aging | Tensile Strength | 11MPa, min | 15MPa, min | Analysis2 | |
| Ultimate Elongation | 300%min | 380%min | Analysis2 | ||
| After | |||||
| Aging | Tensile Strength | 11MPa, min | 15MPa, min | Analysis2 | |
| Ultimate Elongation | 300%min | 380%min | Analysis2 | ||
| 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 |