(216 days)
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 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.
The document provides information about the non-clinical performance evaluation of "Disposable Powder Free Vinyl Examination Gloves, Beige/Clear" to demonstrate its substantial equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| Dimension | ASTM D3767 | Determine the geometrical dimension of gloves | Length: 230 mm min. | Pass |
| Thickness: Palm - 0.08 mm min., Finger - 0.08 mm min. | Pass | |||
| Palm Width: Small 85 ± 5 mm, Medium 95 ± 5 mm, Large 105 ± 5 mm, X Large 115 ± 5 mm | Pass | |||
| Freedom from holes (Water leak) | 21 CFR 800.20. & ASTM D5151-19 | Detect the holes on the gloves. | G-I/AQL 2.5 | Pass |
| Tensile strength (Before/After aging) | ASTM D412-16 & ASTM D573-04 | Evaluate the tensile (tension) properties of the gloves. In addition, it also determines the influence of elevated temperature on the physical properties of gloves. | Before Aging: 11 MPa, min. | Pass |
| After Aging: 11 MPa, min. | Pass | |||
| Elongation (Before/After aging) | ASTM D412-16 & ASTM D573-04 | (purpose as above for tensile strength) | Before Aging: 300% min. | Pass |
| After Aging: 300% min. | Pass | |||
| Powder Residual | ASTM D6124-06 | Determine the average powder mass found on the gloves | < 2mg per glove | Pass |
| Biocompatibility-Skin Irritation | ISO 10993-10:2010 | Determine the potential of glove to promote skin sensitization & irritation reactions after repeated applications | Negative Response | Pass |
| Biocompatibility-Skin Sensitization | ISO 10993-10:2010 | (purpose as above for skin irritation) | No contact sensitization | Pass |
| Biocompatibility-cytotoxicity | ISO 10993-5:2009 | Determine the cytotoxicity potential of glove | No in vitro cytotoxicity | Pass |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each specific test. For instance, for "Freedom from holes," it mentions "G-I/AQL 2.5," which implies a sampling plan, but the exact number of units tested is not provided. The data provenance is not specified beyond being "nonclinical bench testing" conducted by the manufacturer. It does not mention countries of origin for the data or whether it was retrospective or prospective, as these are typically not applicable to bench testing of this nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This section is not applicable as the study involves non-clinical bench testing of physical and chemical properties of gloves, not medical image analysis or diagnostic performance requiring expert interpretation. The "ground truth" is established by adherence to recognized international standards (ASTM, ISO) for material properties.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable as the tests are objective, quantitative measurements against predefined criteria as per ASTM and ISO standards, not subjective assessments requiring adjudication by multiple readers.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable as the device is a medical glove, a physical product, and does not involve AI assistance or human reader interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a medical glove, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device is based on established international standards and specifications for medical gloves, specifically:
- ASTM D3767 (Dimensions)
- 21 CFR 800.20 & ASTM D5151-19 (Freedom from holes)
- ASTM D412-16 & ASTM D573-04 (Tensile strength and Elongation)
- ASTM D6124-06 (Powder Residual)
- ISO 10993-10:2010 (Skin Irritation and Sensitization)
- ISO 10993-5:2009 (Cytotoxicity)
These standards define the acceptable physical properties and biocompatibility.
8. The sample size for the training set
This is not applicable as this study is a non-clinical performance evaluation of a medical device (glove) against established standards, not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
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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
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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
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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 ZoneTaman 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
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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.
| DeviceCharacteristic | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Product Name | Disposable Powder Free VinylExamination Glove,Clear/Yellow | Disposable Powder Free VinylExamination 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 forUse | A patient examination glove is adisposable device intended formedical purposes that is wornon the examiner's hand or fingerto prevent contaminationbetween patient and examiner. | A non-powdered patientexamination glove is adisposable device intended formedical purposes that is wornon the examiner's hand or fingerto prevent contaminationbetween 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 ASTMD5250-06230 mm min. | Complies with ASTMD5250-19230 mm min. | same |
| Dimensions-Palm Width | Complies with ASTMD5250-06Small 85 ± 5Medium 95 ± 5Large 105 ±5X large 115 ±5 | Complies with ASTMD5250-19Small 85 ± 5Medium 95 ± 5Large 105 ±5X large 115 ±5 | same |
| Dimensions-Thickness | Complies with ASTMD5250-06Palm - 0.08mm min.Finger - 0.1 mm min. | Complies with ASTMD5250-19Palm - 0.08 mm min.Finger - 0.08 mm min. | same, bothare thickerthanstandardrequest |
| PhysicalProperties | Tensile StrengthBefore Aging: 11 MPa, min.After Aging: 11 MPa, min.Elongation:Before Aging: 300% min.After Aging: 300% min. | Tensile StrengthBefore 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< 2mg per glove | Complies with ASTMD5250-19< 2mg per glove | same |
| Freedom fromHoles | In accordance with ASTMD5250-06 (G-1 with AQL 2.5) | In accordance with ASTMD5250 -19 (G-1 with AQL 2.5) | same |
| Biocompatibility | ISO 10993-10Skin Sensitization and SkinIrritation test: PassISO 10993-5: not applicable | ISO 10993-10Skin Sensitization and SkinIrritation test: PassISO 10993-5In vitro cytotoxicity test: Pass | similar.Subjectdevice passcytotoxicitytest. |
8.0 Assessment of Non-Clinical Performance Data:
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:
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Image /page/6/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 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 MAIL: INFO@EGVNC0.COM FACEBOOK.COM/PMGLOVESSUPERIEURVIETNAM
510(k) SUMMARY (K221980)
| Test | Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| Dimension | ASTM D3767 | Determine thegeometrical dimensionof gloves | Length: 230 mm min.Thickness:Palm - 0.08 mm min.Finger - 0.08 mm min.Palm Width:Small 85 ± 5 mmMedium 95± 5 mmLarge 105 ± 5 mmX Large 115 ± 5 mm | Pass |
| Freedom fromholes (Water leak) | 21 CFR 800.20.&ASTMD5151-19 | Detect the holes on thegloves. | G-I/AQL 2.5 | Pass |
| Tensile strength(Beforeaging/After aging) | ASTM D412-16& ASTMD573-04 | Evaluate the tensile(tenson) properties ofthe gloves. In addition,it also determines theinfluence of elevatedtemperature on thephysical properties ofgloves. | Before Aging: 11 MPa,min.After Aging: 11 MPa, min | Pass |
| Elongation(Beforeaging/After aging) | ASTM D412-16& ASTMD573-04 | temperature on thephysical properties ofgloves. | Before Aging: 300% min.After Aging: 300% min. | Pass |
| Powder Residual | ASTMD6124-06 | Determine the averagepowder mass found onthe gloves | < 2mg per glove | Pass |
| Biocompatibility-Skin Irritation | ISO10993-10:2010 | determine the potentialof glove to promoteskin sensitization & | Negative Response | Pass |
| Biocompatibility-Skin Sensitization | ISO10993-10:2010 | irritation reactions afterrepeated applications | No contact sensitization | Pass |
| Biocompatibility-cytotoxicity | ISO10993-5:2009 | determine thecytotoxicity potentialof glove | No in vitro cytotoxicity | Pass |
9.0 Assessment of Clinical Performance Data:
Clinical data is not needed for this type of device.
10.0 Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the subject device Disposable Powder Free Vinyl Examination Gloves, Beige/Clear is as safe, as effective, and performs as well as or better than the legally marketed device.
§ 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.