(46 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powered Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.
Here's a breakdown of the acceptance criteria and study information for the Ever Light Powdered (White) Vinyl Patient Examination Gloves, based on the provided text:
Device: Ever Light Plastic Products Co., Ltd. Powdered (White) Vinyl Patient Examination Gloves
Predicate Device: Shijiazhuang Great Eagle Plastic Products Co., Ltd Powdered (White) Vinyl Patient Examination Gloves (K000166)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: (Based on ASTM-D-5250-00E4) | Meets all requirements for physical and dimensions testing conducted on gloves. (Inspection level S-2, AQL 4.0) |
| Pinhole / Water Leak Test: (FDA 1000 ml. Water Fill Test) | Meets requirements. (Sampling AQL 2.5, inspection level I) |
| Primary Skin Irritation: | No primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis): | No sensitization reactions. |
| Residual Powder Content: (Based on ASTM D-6124-06 for Starch) | Meets "powdered" claims (contains no more than 10mg/dm2). |
| Biocompatibility: | Meets biocompatibility requirements (as implied by skin irritation/sensitization results). |
| Labeling Compliance: | No special labeling claims; does not claim gloves as hypoallergenic. |
2. Sample Size Used for the Test Set and Data Provenance
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. (Specific number of units for the sample not provided, but these are statistical sampling plans.)
- Pinhole / Water Leak Test: Sampling AQL 2.5, inspection level I. (Specific number of units for the sample not provided, but these are statistical sampling plans.)
- Primary Skin Irritation and Skin Sensitization: The document does not specify the sample size for the subjects/animals used in the tests.
- Residual Powder Test: "at finished inspection" (specific sample size not provided).
Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of product testing for a 510(k) submission, these would typically be prospective tests conducted by the manufacturer or contracted labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The tests performed are laboratory and material property tests (e.g., physical dimensions, water-fill, chemical analysis, biocompatibility tests), not clinical studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" is established by direct measurement against defined ASTM or FDA standards.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations in clinical studies. The tests described are objective, pass/fail or quantitative measurements against a standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is used to evaluate the diagnostic performance of a medical device (especially those involving image interpretation or clinical decision support) with and without AI assistance, typically involving human readers. The device in question is a patient examination glove, for which such a study is irrelevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
N/A. This refers to AI algorithm performance. The device is a physical product (gloves) and does not involve an algorithm.
7. The Type of Ground Truth Used
The ground truth used for these tests is based on established industry standards and regulatory requirements:
- ASTM-D-5250-00E4: For physical and dimensions testing.
- FDA 1000 ml. Water Fill Test: For pinhole detection.
- ASTM D-6124-06: For residual powder content.
- Biocompatibility testing guidelines: For primary skin irritation and sensitization.
Essentially, the "ground truth" is defined by these measurable standards and the outcome of the tests (e.g., whether a glove leaks, whether it irritates skin, whether it meets dimensional specifications).
8. The Sample Size for the Training Set
Not applicable. There is no "training set" for physical examination gloves. This concept applies to machine learning algorithms where data is used to train a model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for this device type.
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EXHIBIT #1 Page 1 of 2
510(K) SUMMARY
JEC - 8 2006
This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR §807.92.
K063214 The assigned 510(K) number is:
1. Submitter's Identification:
Mr. Yang Ying Ever Light Plastic Products Co., Ltd. Donggao Industrial Zone Zanhuang, Hebei, China 050000
Date Summary Prepared: September 20, 2006
2. Name of the Device:
Ever Light Plastic Products Co., Ltd. Powdered (White) Vinyl Patient Examination Gloves
3. Predicate Device Information:
Shijiazhuang Great Eagle Plastic Products Co., Ltd Powdered (White) Vinyl Patient Examination Gloves (K000166)
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powered Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.
5. Intended Use:
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
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6. Comparison to Predicate Devices:
Ever Light Plastic Products Co., Ltd.'s Powdered (White) Vinyl Patient Examination Gloves is substantially equivalent in safety and effectiveness to the Shijiazhuang Great Eagle Plastic Products Co., Ltd.'s Powdered (White) Vinyl Patient Examination Gloves.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:
The standards used for Ever Light Plastic Products Co., Ltd.'s glove production are based on ASTM-D-5250-00E4. All testing meets requirements for physical and dimensions testing conducted on gloves. Inspection level S-2, AQL 4.0.
The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, inspection level I, meeting these requirements.
Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions.
A Residual Powder Test that based on ASTM D-6124-06 for Starch at finished inspection is conducted to insure that our gloves meet our "powdered" claims (contain no more than 10mg/dm2).
8. Labeling:
There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels.
9. Discussion of Clinical Tests Performed:
Not Applicable - There is no hypoallergenic Claim.
10. Conclusions:
Ever Light Plastic Products Co., Ltd.'s Powdered (White) Vinyl Patient Examination Gloves conform fully to ASTM D-5250-00E4 standard as well as applicable 21 CFR references, and meets 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings spread and tail feathers flowing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 8 2006
Ever Light Plastic Products Company Limited C/O Ms. Kathy Liu Gloveco, Incorporated 3973 Schaefer Avenue Chino, California 91710
Re: K063214
Trade/Device Name: Powdered (White) Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: September 20, 2006 Received: October 24, 2006
Dear Ms. Liu:
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 – Ms. Liu
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); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Snyde y. Michuoms
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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Attachment A
INDICATION FOR USE
510 (k) NUMBER (IF KNOW): APPLICANT: DEVICE NAME:
KO63214 Ever Light Plastic Products Co., Ltd. Powdered (White) Vinyl Patient Examination Gloves
INDICATIONS FOR USE:
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use
(Optional Format 1-2-96) $\surd$
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrent of CDRH, Office of Device Evaluation (ODE)
Starkie Haughey D
nas hesiology, General Hospits i Control. Dental Devices
§ 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.