(86 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 technologies.
No
The device is described as examination gloves used to prevent contamination, which is a preventive measure, not a therapeutic intervention.
No
This device is a medical glove, used to prevent contamination, not to diagnose a condition or disease.
No
The device is a physical product (gloves) and the description focuses on material properties and performance standards for a physical barrier. There is no mention of software components or functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "worn on the examiner's hands to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description focuses on the physical properties and standards related to the glove's material and performance as a barrier.
- Lack of Diagnostic Function: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status or condition.
- No Mention of IVD-Specific Standards or Tests: The standards mentioned (ASTM D6124, ASTM D5151, ASTM D5250, ISO 10993) are related to the physical properties, safety, and performance of gloves as a barrier, not to diagnostic testing.
- Key Metrics: The key metrics listed (Tensile Strength, Ultimate Elongation, Freedom from Holes, Powder Content, Irritation, Sensitization, Cytotoxicity) are all related to the glove's physical integrity and biocompatibility, not diagnostic accuracy.
In summary, this device is a medical device intended for barrier protection, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The Vinyl Examination Gloves(Yellow) is a disposable device 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 yellow. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.
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
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 D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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.
March 12, 2021
Lutai Medical Technology Co.,LTD. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608.No.738,Shangcheng Rd.,Pudong Shanghai, 200120 Cn
Re: K203666
Trade/Device Name: Vinyl Examination Gloves(Yellow) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: December 2, 2020 Received: December 16, 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
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,
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) K203666
Device Name Vinyl Examination Gloves(Yellow)
Indications for Use (Describe)
The Vinyl Examination Gloves(Yellow) is a disposable device 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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3
510(k) Summary
K203666
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's Information
LUTAI MEDICAL TECHNOLOGY CO.,LTD. Name: Address: Tiandingfeng Road, Dezhou City 251500, Shandong, China. Phone Number: Contact: Xiaomeng Li Date of Preparation: 12/03/2020
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: Vinyl Examination Gloves(Yellow)
Common name: Vinyl Patient Examination Glove
Classification name: Non-powdered Patient Examination Glove
Model(s): S, M, L, XL
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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
5.0 Indication for Use
The Vinyl Examination Gloves(Yellow) is a disposable device intended for medical purposes that is worn on the examiner's 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 yellow. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.
7.0 Technological Characteristic Comparison Table
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| Item | Subject device | Predicated device | Comparison |
|---|---|---|---|
| 510(k) number | K203666 | K163168 | Different |
| Product Code | LYZ | LYZ | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Intended Use | The Vinyl Examination | ||
| Gloves(Yellow) 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 Device Designation | Size | Tolerance | |||||
|---|---|---|---|---|---|---|---|
| (K163168) | XS | ട | M | L | XL | ||
| Length, mm | 230 | 230 | 235 | 245 | 245 | min | |
| Width, mm | 80 | 85 | ત્ત્વનીયારી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધ | 105 | 115 | +5 | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min |
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| Palm | 0.08 | min | |||||
|---|---|---|---|---|---|---|---|
| Subject Device | |||||||
| (K203666) | Designation | Size | Tolerance | ||||
| S | M | L | XL | ||||
| Length, mm | 240 | 240 | 240 | 240 | $\pm$ 10 | ||
| Width, mm | 85 | 95 | 105 | 115 | $\pm$ 5 | ||
| Thickness, mm: | |||||||
| Finger | 0.10 | min | |||||
| Palm | 0.08 | min | |||||
| Remark | Similar |
Analysis: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D5250,so the differences do not raise any new safety or performance questions.
| Item | Subject device | Predicated device | Comparison | ||
|---|---|---|---|---|---|
| Colorant | Yellow | White, Blue, Yellow | Different (Analysis 1) | ||
| Physical Properties | Before Aging | Tensile Strength | 11MPa, min | 15MPa, min | Different (Analysis 2) |
| Ultimate Elongation | 300%min | 380%min | Different (Analysis 2) | ||
| After Aging | Tensile Strength | 11MPa, min | 15MPa, min | Different (Analysis 2) | |
| Ultimate Elongation | 300%min | 380%min | Different (Analysis 2) | ||
| Comply with ASTM D5250 | Comply with ASTM D5250 | Same | |||
| Freedom from Holes | Be free from holes when | Be free from holes when tested in | Same |
Table3 Performance Comparison
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| | tested
in
accordance with
ASTM D5151
AQL=2.5 | in accordance with
ASTM D5151
AQL=2.5 | |
|----------------|----------------------------------------------------------|---------------------------------------------|---------|
| Powder Content |