(29 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.
The provided text is a 510(k) summary for a disposable powdered vinyl exam glove. It outlines the device's characteristics and its equivalence to a predicate device but does not contain the details of a study that proves the device meets specific acceptance criteria in the way a clinical study for a diagnostic or therapeutic device would.
Instead, the "acceptance criteria" here relate to compliance with established industry standards and regulatory requirements for medical gloves. The "study" refers to the non-clinical tests performed to demonstrate this compliance.
Here's the information broken down based on your request, with an emphasis on what is (and isn't) available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: | Meets requirements per ASTM D5250-00E4 (Inspection level S-2, AQL 4.0) |
| Watertight Test (Pinhole): | Meets requirements per FDA 1000 ml Watertight Test based on ASTM D-5151-99 (Samplings of AQL 2.5, Inspection level I) |
| Primary Skin Irritation: | No primary skin irritant reactions |
| Skin Sensitization (Allergic Contact Dermatitis): | No sensitization reactions |
| Material/Construction: | Vinyl Examination Glove, Powdered, Yellow Color (Equivalent to predicate K932054, with color additive difference) |
| Biocompatibility: | Meets biocompatibility requirements (Implied by skin irritation/sensitization results) |
| Labeling Claims: | Meets labeling claims (No hypoallergenic claim made) |
| Regulatory Compliance: | Conforms fully to ASTM D-5250-00E4 standard and applicable 21 CFR references (e.g., 21 CFR 880.6250) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For Physical and Dimensions Testing: "Inspection level S-2, AQL 4.0". The exact number of gloves tested is dependent on lot size and the AQL tables, which are not specified here.
- For Watertight Test: "Samplings of AQL 2.5, Inspection level I". Similar to above, the exact number tested is not specified but determined by AQL tables and lot size.
- For Primary Skin Irritation and Skin Sensitization: Not specified, but typically involves a certain number of animal subjects (e.g., guinea pigs) or human volunteers for patch tests.
- Data Provenance: Not explicitly stated, but given the submitter is from Vietnam ("Long Thanh Industrial Zone Taman Village, Long Thanh District Dong Nai Province, Vietnam") and the tests were performed "for Ever Global Enterprise Corporation's glove production," it's highly likely the testing was conducted by or for the manufacturer in their facilities or contracted labs, possibly within Vietnam, specifically for this device. The data is prospective with respect to the regulatory submission, as it was generated to support the 510(k).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This device is a Class I medical glove. The "ground truth" for its performance is based on adherence to established consensus standards (ASTM) and regulatory tests (FDA watertight test, biocompatibility). These standards define objective pass/fail criteria, rather than requiring expert consensus on subjective interpretations (like reading medical images). The experts involved would be laboratory technicians and quality assurance personnel following standard protocols, not medical specialists establishing clinical ground truth.
4. Adjudication Method for the Test Set
- Not Applicable. As mentioned above, the tests are objective and follow predefined methodologies from ASTM and FDA. They do not involve subjective interpretation requiring an adjudication process by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. An MRMC study is relevant for diagnostic devices where human readers interpret data (e.g., radiologists reading images) and the AI's impact on their performance (e.g., accuracy, efficiency) is measured. This device is a physical barrier (glove), not a diagnostic tool, so an MRMC study is not relevant or applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This is a physical product (glove), not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used
- The "ground truth" here is defined by established consensus standards and objective test methodologies:
- ASTM D5250-00E4: Standard Specification for Poly(vinyl chloride) Gloves for Medical Application. This standard defines physical properties and dimensions.
- ASTM D-5151-99: Standard Test Method for Detection of Holes in Medical Gloves. This defines the watertight test.
- Biocompatibility testing guidelines: These would define the methodology for primary skin irritation and sensitization tests.
- The device's performance is measured against these objective, predefined criteria.
8. The Sample Size for the Training Set
- Not Applicable. This device is a physical product, not an AI/ML algorithm. There is no "training set" in the context of machine learning. The manufacturing process of gloves involves quality control and process validation, which might involve large amounts of data, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no AI training set, this question is not relevant. The "ground truth" for the glove's manufacturing refers to the product specifications and quality standards that the manufacturing process aims to meet.
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JUL 6 - 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 15, 2005
2. Name of the Device:
Ever Global Enterprise Corporation Disposable Powdered Vinyl Exam Glove Yellow Color
3. Predicate Device Information:
Assured Medical Supply Company, Ltd. Vinyl Examination Glove (K932054)
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 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:
Ever Global Enterprise Corporation's Disposable Powdered Vinyl Exam Glove, Yellow Color is substantially equivalent to the device manufactured by Assured Medical Supply Company, Ltd. (K932054) 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:
The standards used for Ever Global Enterprise Corporation's glove production are Based on ASTM D5250-00E4. All testing meets requirements for Physical and 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, mecting these requirements. Primary Skin irritation and Skin Sensitization (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.
8. Discussion of Clinic Tests Performed:
Not applicable - There is no Hypoallergenic Claim.
9. Conclusions:
Ever Global Enterprise Corporation's Disposable Powdered Vinyl Exam Glove, Yellow Color conform fully to ASTM D-5250-00E4 standard as well as applicable 21CFR references, and, mects pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 6 - 2005
Mr. Nick Bien Manager Ever Global Enterprise Corporation Long Thanh Industrial Zone Taman Village, Long Thanh District Dong Nai Province, VIETNAM
Re: K051498
Trade/Device Name: Disposable Powdered Vinyl Exam Glove Yellow Color Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: April 15, 2005 Received: June 7, 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. Bien
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 Dr may Federal statutes and regulations administered by other Federal agencies. or the Fee or 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 iboms (s as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirelies 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) I mis letter will and in J . 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), n you desire specifica 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 may overn 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,
Chau-Lin, Ph.D.
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
Applicant: EVER GLOBAL ENTERPRISE CORPORATION
510(k) Number (if known): __ L = 57498
Device Name: Disposable Powdered 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 __ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use __ X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
PAGE OF NEEDED)
4
Concurrence of CDRH, Office of Device Evaluation (ODE)
6
Shirl A. Murphy 7/15/05
esthesiology, General Hospital, ontrol Denta
510(k) Number: K05145
§ 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.