(61 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00E4.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Disposable Powder Free Vinyl Exam Glove, Yellow Color:
This document is a 510(k) summary for a medical device (a disposable glove), not a typical AI/ML medical device submission. Therefore, many of the requested categories (like MRMC study, ground truth for training set, number of experts for ground truth, etc.) are not applicable as they relate to advanced diagnostic or AI-driven devices. The focus here is on demonstrating substantial equivalency to a predicate device through established physical performance and biocompatibility standards.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ASTM D5250-00E4 (Overall Standard) | Conforms fully |
| Dimensions Testing (AQL 4.0, S-2) | Meets requirements¹ |
| FDA 1000 ml Watertight Test | Meets requirements¹ |
| (ASTM D-5151-99, AQL 2.5, Insp. Level I) | |
| Primary Skin Irritation/Sensitization | No primary skin irritant or sensitization reactions |
| Residual Powder Test (ASTM D6124-01) | Meets "powder-free" claims (contains no more than 2 mg powder per glove) |
| Biocompatibility | Meets requirements¹ |
| Pinhole FDA requirements | Meets requirements¹ |
¹ The document states the device "meets these requirements" or "conforms fully" or "meets requirements" without providing specific measured values for dimensions, watertight test, biocompatibility, or pinhole requirements in the summary. It refers to data in Section 7 which is not fully elaborated with raw numbers.
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Dimensions Testing: Inspection level S-2, AQL 4.0. (Specific sample size 'n' is not explicitly stated, but derived from AQL and inspection levels).
- FDA 1000 ml Watertight Test: AQL 2.5, Inspection level I. (Specific sample size 'n' is not explicitly stated, but derived from AQL and inspection levels).
- Primary Skin Sensitization Test: Not specified.
- Residual Powder Test: Not specified.
- Data Provenance: The manufacturing company is Ever Global Enterprise Corporation, based in Dong Nai Province, Vietnam. The tests were likely conducted on gloves produced at this facility. The document doesn't explicitly state if the testing was prospective (done specifically for this submission) or retrospective (using existing factory QA data), but it's implied to be part of the product's quality assurance and validation for this submission.
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)
Not applicable. This device is a physical product (a glove), not a diagnostic device requiring expert interpretation for ground truth. Performance is measured against established physical and chemical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or subjective assessments that would require an adjudication method.
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
Not applicable. This device is not an AI-driven or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is defined by adherence to established national and international standards for medical examination gloves, specifically:
- ASTM D5250-00E4 (Standard specification for Vinyl Examination Gloves for Medical Application)
- ASTM D-5151-99 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-01 (Standard Test Method for Residual Powder on Medical Gloves)
- FDA's 1000 ml Watertight Test (which cites ASTM D-5151-99)
- Biocompatibility requirements (Primary Skin Sensitization)
These standards define objective measurement criteria rather than requiring subjective human "ground truth" interpretation.
8. The sample size for the training set
Not applicable. This device is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML model that requires a training set.
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JUL 2 7 2005
510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in Accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(K) number is:
1. Submitter's Identification:
Mr. Nick Bien Ever Global Enterprise Corporation Long Thanh Industrial Zone Taman Village, Long Thanh District Dong Nai Province, Vietnam
Date Summary Prepared: April 5, 2005
2. Name of the Device:
Ever Global Enterprise Corporation Disposable Powder Free Vinyl Exam Glove Yellow Color
3. Predicate Device Information:
Safehealth Medical Supply Corp Vinyl Examination Glove,Powder Free (K955091)
4. Device description:
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00E4.
5. Intended Use:
A patient examination glove is a disposable device intended for medical purposes . I parceller in ...
that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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6.Comparison to Predicate Devices:
Comparison to I realleries Disposable Powder Free Vinyl Exam Glove,
Ever Global Enterprise Corporation's Disposable Powder Free Schoolth Evel Cloudi Linerprise Corporation
Yellow Color is substantially equivalent to the device manufactured by Safehealth Yenow Color is submansany -11
Medical Supply Corp. (K955091) except for the yellow color additive being added to this glove.
7. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows:
Substantial Data. In Ever Global Enterprise Corporation's glove production are
The standards used for Ever Global Enterprise Corporation of Picture The standards about 11 Dimensions Testing conducted on gloves, Inspection level S-2, AQL 4.0.
The FDA 1000 ml Watertight Test based on ASTM D-5151-99 was also conducted with samplings of AQL 2.5, Inspection level I, meeting these requirements. Primary With samplings of Pressitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.
A residual Powder test that based on ASTM D6124-01 for Starch at finished A residual I oware 1997 ...
inspection is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per gloves)
8. Discussion of Clinic Tests Performed:
Not applicable – There is no Hypoallergenic Claim.
9. Conclusions:
Collectusions. I:VEl Olooal Linerprise Carp .
Yellow Color conform fully to ASTM D-5250-00E4 standard as well as applicable Tenow Octor of the same
21CFR references, and, meets pinhole FDA requirements, biocompatibility zTCPA references, and labeling claims as shown by data in Section 7. There are no requirements and november of the "substantial equivalence" products cited.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the words "U.S. Department of Health and Human Services, Inc." in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 27 2005
Mr. Nick Bien Manager Ever Global Enterprise Corporation Long Thanh Industrial Zone, Taman Village, Long Thanh District, Dong Nai Province, VIETNAM
Re: K051393
Trade/Device Name: Disposable Powder Free Vinyl Exam Glove, Yellow Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: July 6, 2005 Received: July 20, 2005
Dear Mr. Bein:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Bein
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 mount that I I any Federal statutes and regulations administered by other Federal agencies. or are For of any with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and if moments as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Switte y. Michael Omd
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
EVER GLOBAL ENTERPRISE CORPORATION Applicant:
510(k) Number (if known): K051393
Device Name: Disposable Powder Free Vinyl Exam Glove Yellow Color
Indications for Use:
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
| Prescription Use | |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | X |
|---|---|
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
PAGE ADD 6-1
510(k) Number: K051393
7/26/05
§ 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.