(216 days)
No
The description focuses on the material properties and barrier function of a standard examination glove, with no mention of AI/ML or related concepts.
No.
The device is a patient examination glove, which serves as a barrier to prevent contamination, not to treat or cure a medical condition.
No
Explanation: The provided text states the device prevents "contamination between patient and examiner" and acts as a "barrier protection." It does not mention any function related to diagnosing a condition or disease.
No
The device is a physical glove made from poly (vinyl chloride) and is described as a disposable device worn on the hand or finger. It does not mention any software components.
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)), the physical properties (barrier protection, tensile properties), and compliance with a standard for medical gloves (ASTM D5250-19). There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition.
This device falls under the category of a medical device used for barrier protection, specifically a patient examination glove.
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 Examination Gloves (with color Beige or Clear) is a patient examination glove made from poly (vinvl chloride), non-sterile (as per 21 CFR 880.6250, Class I). 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 (examiner's)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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 following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device. Disposable Powder Free Vinyl Examination Gloves, Beige/Clear Color made by Ever Global (Vietnam) Enterprise Corporation met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device. No new safety or performance issues were raised during testing:
Test - Dimension
- Test Method: ASTM D3767
- Purpose: Determine the geometrical dimension of gloves
- Acceptance Criteria: 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
- Results: Pass
Test - Freedom from holes (Water leak)
- Test Method: 21 CFR 800.20. & ASTM D5151-19
- Purpose: Detect the holes on the gloves.
- Acceptance Criteria: G-I/AQL 2.5
- Results: Pass
Test - Tensile strength (Before aging/After aging)
- Test Method: ASTM D412-16 & ASTM D573-04
- Purpose: Evaluate the tensile (tenson) properties of the gloves. In addition, it also determines the influence of elevated temperature on the physical properties of gloves.
- Acceptance Criteria: Before Aging: 11 MPa, min.; After Aging: 11 MPa, min
- Results: Pass
Test - Elongation (Before aging/After aging)
- Test Method: ASTM D412-16 & ASTM D573-04
- Purpose: [Implicitly, determining the influence of elevated temperature on the physical properties of gloves, similar to Tensile strength]
- Acceptance Criteria: Before Aging: 300% min.; After Aging: 300% min.
- Results: Pass
Test - Powder Residual
- Test Method: ASTM D6124-06
- Purpose: Determine the average powder mass found on the gloves
- Acceptance Criteria:
§ 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 6, 2023
Ever Global (Vietnam) Enterprise Corporation Elizabeth Deng US Agent 5748 Eaglewood Place Rancho Cuamonga, California 91739
Re: K221980
Trade/Device Name: Disposable Powder Free Vinyl Examination Gloves, Beige/Clear Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: January 18, 2023 Received: January 20, 2023
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
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,
Bifeng Qian -S
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) K221980
Device Name
Disposable Powder Free Vinyl Examination Gloves, Beige/Clear
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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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 the 'E' being larger than the 'G'. Behind the letters is a blue handprint. The words 'EVER GLOBAL' are at the top of the logo, and 'ENTERPRISE CORP' is at the bottom.
LONG THANH INDUSTRIAL ZONE, TAMAN VILLAGE, DONG FAX: (0251)351 4023 024 IGLOVESSUPERIEURVIETNAM
510(k) SUMMARY (K221980)
0.0 Summary Preparation Date: Jan 31, 2023
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
909 4659188
5748 Eaglewood Place
Rancho Cucamonga, California Rancho Cucamonga, CA 91739
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:
4.0 Predicate device Device Name:
Company name: 510(K) Number:
Disposable Powder Free Vinyl Examination Gloves, Beige/Clear 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' and 'G' in a stylized, overlapping design in yellow. 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 blue.
LONG THANH INDUSTRIAL ZONE, TAMAN VILLAGE, DONG FAX: (0251)351 4023 02 ACEBOOK.COM/PMGLOVESSUPERIEURVIETNAM
510(k) SUMMARY (K221980)
5.0 Device Description:
A Disposable Powder Free Vinyl Examination Gloves (with color Beige or Clear) is a patient examination glove made from poly (vinvl chloride), non-sterile (as per 21 CFR 880.6250, Class I). 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 | ||
| Examination Gloves, | |||
| Beige/Clear | similar glove | ||
| 510(K) No. | K170525 | K221980 | 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 |
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 a large, stylized "EG" in gold, superimposed on a light blue hand. The words "EVER GLOBAL" are written in blue above the "EG", and "ENTERPRISE CORP" is written in blue below the "EG".
Long Thanh Industrial Zone, Taman Village, Dong NAI 810000 VIETNAM TEL: (0251) 896 6676 FAX: (0251)351 4023 024 EMAIL: INFO@EGVNC0.COM FACEBOOK.COM/PMGLOVESSUPERIEURVIETNAM
510(k) SUMMARY (K221980)
| Device Characteristic | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Dimensions- | |||
| Length | Complies with ASTM | ||
| D5250-06 | |||
| 230 mm min. | Complies with ASTM | ||
| D5250-19 | |||
| 230 mm min. | same | ||
| 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 |