(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 L YZ, and meets all requirements of ASTM standard D-5250-00E4.
The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Ever Light Plastic Products Co., Ltd. Powdered (Yellow) Vinyl Patient Examination Gloves.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: Based on ASTM-D-5250-00E4 | All testing meets requirements for physical and dimensions testing. |
| Pinholes (Water Leak Test): FDA 1000 ml. Water Fill Test, AQL 2.5, Inspection Level I | Meets requirements. |
| Primary Skin Irritation: | No primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis): | No sensitization reactions. |
| Residual Powder: Based on ASTM D-6124-06 for Starch, no more than 10mg/dm² | Meets "powdered" claims (contains no more than 10mg/dm²). |
2. Sample size used for the test set and the data provenance
- Sample Size for Physical and Dimensions Testing: Not explicitly stated as a fixed number, but refers to "samplings" and an "inspection level S-2" with "AQL 4.0". This implies a statistical sampling plan rather than a fixed sample size.
- Sample Size for Pinholes (Water Fill Test): Refers to "samplings of AQL 2.5, inspection level I". This also implies a statistical sampling plan.
- Sample Size for Primary Skin Irritation and Skin Sensitization: Not explicitly stated.
- Sample Size for Residual Powder Test: Not explicitly stated.
- Data Provenance: The studies were conducted by Ever Light Plastic Products Co., Ltd. for their product. It is a prospective evaluation of their manufactured gloves. The country of origin of the data would be China, where the manufacturer is located.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. The "ground truth" for glove performance is established by standardized testing protocols (e.g., ASTM standards, FDA water fill test) and expert judgment is not typically involved in the same way it would be for diagnostic imaging or clinical outcomes studies. The reported performance is based on direct measurements and observations during these tests.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods are typically used in studies involving subjective interpretations (e.g., by multiple readers) to resolve discrepancies. For objective performance measures of medical gloves, such as physical properties, leak tests, or biocompatibility, direct measurements are taken, and no adjudication by multiple experts is required.
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 information is not applicable. This submission is for a medical device (patient examination gloves) that is not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. As mentioned above, this is not an AI algorithm. The performance evaluation is of the physical and biological characteristics of the gloves themselves.
7. The type of ground truth used
The "ground truth" for the performance of these gloves is defined by:
- Performance specifications and testing methods outlined in ASTM-D-5250-00E4.
- FDA requirements for pinholes (1000 ml. Water Fill Test).
- Standardized biocompatibility testing for irritation and sensitization.
- Standardized testing method for residual powder (ASTM D-6124-06).
These standards define the acceptable range or threshold for each property, forming the objective "ground truth" for compliance.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of physical medical devices like examination gloves. The manufacturing process of gloves is not an AI model that requires training data. Instead, there are quality control and acceptance sampling processes during manufacturing.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" for this device.
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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.
The assigned 510(K) number is: K 063215
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 (Yellow) Vinyl Patient Examination Gloves
3. Predicate Device Information:
Shijiazhuang Great Eagle Plastic Products Co., Ltd Powdered Vinyl Patient Examination Gloves (Yellow) (K992862)
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 L YZ, 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 (Yellow) Viny) Patient Examination Gloves is substantially equivalent in safety and effectiveness to the Shijiazhuang Great Eagle Plastic Products Co., Ltd.'s Powdered Vinyl Patient Examination Gloves (Yellow).
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/dm4).
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 (Yellow) 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 is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the edge. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right and has three stripes on its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ever Light Plastic Products Company, Limited C/O Ms. Kathy Liu Official Correspondent Gloveco, Incorporated 3973 Schaefer Avenue Chino, California 91710
DEC - 8 2006
Re: K063215
Trade/Device Name: Powdered (Yellow) Vinyl Patient Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Glove 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 (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,
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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INDICATION FOR USE
KO63215
510 (k) NUMBER (IF KNOW): APPLICANT: DEVICE NAME:
Ever Light Plastic Products Co., Ltd. Powdered (Yellow) 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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrent of CDRH, Office of Device Evaluation (ODE)
Shila f. Murphy MD
Control, Dental DeviceS
K 063215
§ 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.