(198 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier protection of a disposable examination glove, with no mention of AI or ML.
No
The device is a patient examination glove, which serves as a barrier to prevent contamination, not to treat or cure a disease or condition.
No
Explanation: The device is described as a glove that acts as a barrier to prevent contamination. It does not perform any diagnostic function such as detecting, identifying, or monitoring a disease or condition.
No
The device is a physical glove made of poly (vinyl chloride) and is described as a disposable device worn on the hand or finger. It is clearly a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a barrier device worn on the hand or finger to prevent contamination between patient and examiner. This is a physical barrier function, not a diagnostic test performed on a sample from the body.
- Device Description: The description focuses on the material (poly (vinyl chloride)), physical properties (non-sterile, sizes), and performance standards related to barrier protection and tensile strength. These are characteristics of a physical barrier device, not a diagnostic one.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze a sample (blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
- Performance Studies: The performance studies listed (Dimension, Freedom from holes, Tensile strength, etc.) are all related to the physical integrity and barrier function of the glove, not to the accuracy or reliability of a diagnostic test.
- Predicate Device: The predicate device is also a "Disposable Powder Free Vinyl Examination Glove," reinforcing the classification as a barrier device.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
LYZ
Device Description
A Disposable Powder Free Vinyl Exam Glove (with color Black, Blue, or Purple) is a patient examination glove made from poly (vinyl chloride), non-sterile (as per 21 CFR 880.6250, Class I). This device is available in size S, M, L, and XL. The operation principle of this medical device is 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 D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
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
medical purposes / 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)
The device underwent non-clinical performance testing.
Key results:
- Dimension: Pass (Length: 230 mm min., Thickness: Palm - 0.08 mm min., Finger - 0.08 mm min., Palm Width: Small 85 ± 5 mm, Medium 95± 5 mm, Large 105 ± 5 mm, X Large 115 ± 5 mm)
- Freedom from holes (Water leak): Pass (G-I/AQL 2.5)
- Tensile strength (Before aging/After aging): Pass (Before Aging: 11 MPa, min., After Aging: 11 MPa, min.)
- Elongation (Before aging/After aging): Pass (Before Aging: 300% min., After Aging: 300% min.)
- Powder Residual: Pass (
§ 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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 19, 2022
Ever Global (Vietnam) Enterprise Corporation % Elizabeth Deng US Agent Elizabeth Deng 5748 Eaglewood Place Ranch Cucamonga, California 91739
Re: K220992
Trade/Device Name: Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: September 15, 2022 Received: September 19, 2022
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.
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 (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.
Bifeng Qian, M.D., Ph.D. 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) K220992
Device Name
Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple
Indications for Use (Describe)
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.
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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FORM FDA 3881 (6/20)
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Image /page/3/Picture/1 description: The image is a logo for Ever Global Enterprise Corp. The logo features the letters 'Eg' in yellow, with 'E' being larger than 'g'. Behind the letters is a blue hand. The words 'EVER GLOBAL' are at the top of the logo, and 'ENTERPRISE CORP.' is at the bottom, both in white text on a blue background.
LONG THANH INDUSTRIAL ZONE, TAMAN VILLAGE, DONG FAX: (0251)351 4023 024 BOOK.COM/PMGLOVESSUPERIEURVIETNAM
510(k) SUMMARY
The assigned 510(k) Number: K220992
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.
0.0 Summary Preparation Date: -Oct 18th, 2022
1.0 Submitter:
| Submitter's name : | Ever Global (Vietnam) Enterprise Corporation |
|---|---|
| Submitter's address: | Long Thanh Industrial Zone |
| Taman Village Dong Nai Province, VN 810000 | |
| Phone number: | 84-61-3514022 |
| Fax number: | 84-61-3514023 |
| Name of contact person: | Jerry Lin |
Elizabeth Deng
2.0 US Agent:
US Representative Name: Company Address:
Telephone Number: Contact Email Address:
5748 Eaglewood Place Rancho Cucamonga, California Rancho Cucamonga, CA 91739 909 4659188 baxianunited48(@yahoo.com
3.0 Name of the Device
Proprietary/Trade name:
Common Name: Classification Name: Device Classification: Regulation Number: Product Code:
4.0 Predicate device
Device Name:
Company name: 510(K) Number: Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple Vinyl Examination Gloves Non-powdered Patient Examination Glove Class I 21 CFR 880.6250 LYZ
Disposable Powder Free Vinyl Examination Glove, Clear/Yellow Ever Global (Vietnam) Enterprise Corporation K170575
4
Image /page/4/Picture/1 description: The image is a logo for Ever Global Enterprise Corp. The logo features the letters 'E', 'G', and 'C' in yellow, superimposed on a blue hand. The words 'EVER GLOBAL' are at the top of the logo, and 'ENTERPRISE CORP.' is at the bottom. The logo is framed by a blue border.
LONG THANH INDUSTRIAL ZONE, TAMAN VILLAGE, DONG NAI 810000 VIETNA AX: (0251)351 4023 024 ACEBOOK.COM/PMGLOVESSUPERIEURVIETNAM
510(k) SUMMARY
The assigned 510(k) Number: K220992
5.0 Device Description:
A Disposable Powder Free Vinyl Exam Glove (with color Black, Blue, or Purple) is a patient examination glove made from poly (vinyl chloride), non-sterile (as per 21 CFR 880.6250, Class I). This device is available in size S, M, L, and XL. The operation principle of this medical device is 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 D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
6.0 Device Indications for use:
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.
| Device
| Characteristic | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Product Name | Disposable Powder Free Vinyl | ||
| Examination Glove, | |||
| Clear/Yellow | Disposable Powder Free Vinyl | ||
| Exam Glove, Black/Blue/Purple | Same except | ||
| color | |||
| 510(K) No. | K170525 | K220992 | n/a |
| Product Owner | Ever | ||
| Global | |||
| (Vietnam) | |||
| Enterprise Corporation | Ever | ||
| Global | |||
| (Vietnam) | |||
| Enterprise Corporation | same | ||
| Product Code | LYZ | LYZ | same |
| Regulation | 21 CFR 880.6250 | 21 CFR 880.6250 | same |
| Class | I | I | same |
| Indications for | |||
| Use | 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. | 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. | same | ||
| Power free | Yes | Yes | same |
| Size | Small/ Medium/Large/X Large | Small/Medium/Large/X Large | same |
| Over-The- | |||
| Counter Use | Yes (21 CFR 801 Subpart C) | Yes (21 CFR 801 Subpart C) | same |
| Single Use | YES | YES | same |
| Non-Sterile | YES | YES | same |
| Dimensions- | |||
| Length | Complies with ASTM D5250-06 | ||
| 230 mm min. | Complies with ASTM D5250-19 | ||
| 230 mm min. | same |
7.0 Comparison of device technological characteristics:
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Image /page/5/Picture/1 description: The image is a logo for Ever Global Enterprise Corp. The logo features the letters 'F' and 'g' in a stylized font, with the letters overlapping each other. The letters are yellow, and they are set against a blue background that resembles a hand. The words 'EVER GLOBAL' are at the top of the logo, and the words 'ENTERPRISE CORP.' are at the bottom.
Long Thanh Industrial Zone, Taman Village, Dong NAI 810000 VIETNAM TEL: (0251) 896 6676 FAX: (0251)351 4023 024 EMAIL: INFO@EGVNCO.COM FACEBOOK.COM/PMGLOVESSUPERIEURVIETNAM
510(k) SUMMARY
The assigned 510(k) Number: K220992
| Device
| Characteristic | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Dimensions - | |||
| Palm Width | Complies with ASTM D5250-06 | ||
| Small 85 ± 5 | |||
| Medium 95 ± 5 | |||
| Large 105 ± 5 | |||
| X large 115 ± 5 | Complies with ASTM D5250-19 | ||
| Small 85 ± 5 | |||
| Medium 95 ± 5 | |||
| Large 105 ± 5 | |||
| X large 115 ± 5 | same | ||
| Dimensions - | |||
| Thickness | Complies with ASTM D5250-06 | ||
| Palm - 0.08mm min. | |||
| Finger - 0.1 mm min. | Complies with ASTM D5250-19 | ||
| Palm - 0.08 mm min. | |||
| Finger - 0.08 mm min. | same, both | ||
| are thicker | |||
| than | |||
| standard | |||
| request | |||
| Physical | |||
| Properties | Tensile Strength | ||
| Before Aging: 11 MPa, min. | |||
| After Aging: 11 MPa, min. | |||
| Elongation: | |||
| Before Aging: 300% min. | |||
| After Aging: 300% min. | Tensile Strength | ||
| Before Aging: 11 MPa, min. | |||
| After Aging: 11 MPa, min. | |||
| Elongation: | |||
| Before Aging: 300% min. | |||
| After Aging: 300% min. | same | ||
| Residual | |||
| powder | Complies with D5250-06 |