(43 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, Power-Free Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Ever Light Plastic Products Co., Ltd. Powder Free (White) Vinyl Patient Examination Gloves:
Device: Ever Light Plastic Products Co., Ltd. Powder Free (White) Vinyl Patient Examination Gloves
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Test Name | Standard / Requirement | Reported Device Performance |
|---|---|---|
| Physical and Dimensions Testing (General) | ASTM-D-5250-00E4 | Meets requirements for physical and dimensions testing. |
| Physical and Dimensions Testing (AQL) | Inspection level S-2, AQL 4.0 | Meets requirements. |
| Pinhole Test (Water Fill Test) | FDA 1000 ml. Water Fill Test, AQL 2.5, inspection level I | Meets requirements. |
| Primary Skin Irritation | Not explicitly stated, implied to prevent irritation | No primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis) | Not explicitly stated, implied to prevent sensitization | No sensitization reactions. |
| Residual Powder Test | ASTM D6124-06 (for Starch), ≤ 2 mg powder per glove | Meets "powder-free" claims (contains no more than 2 mg powder per glove). |
| Biocompatibility | Applicable 21 CFR references (implied requirement for patient contact devices) | Meets biocompatibility requirements. |
| General Safety/Efficacy | Substantial equivalence to predicate device (K000071), no new claims | No safety/efficacy issues or new claims compared to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The text does not provide a specific number of gloves, but specifies the AQL (Acceptable Quality Level) and inspection level, which are standard statistical sampling methods for quality control. This is likely a retrospective evaluation of manufacturing batches.
- Pinhole Test (Water Fill Test): AQL 2.5, inspection level I. Similar to the above, a specific number isn't given, but the sampling plan is defined. This is likely a retrospective evaluation of manufacturing batches.
- Primary Skin Irritation and Skin Sensitization: The text states these tests were "conducted" but does not specify the sample size of subjects or the exact provenance of the data (e.g., specific country or demographic). It's broadly a prospective test on human or animal subjects to assess biological response.
- Residual Powder Test: The test is "conducted at finished inspection" to ensure compliance. The sample size or specific provenance isn't detailed, but it's part of standard retrospective quality control during manufacturing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. The tests described are primarily objective, quantitative measurements (e.g., physical dimensions, water-fill, chemical analysis, biocompatibility assessments). They do not rely on expert consensus for "ground truth" in the way a diagnostic imaging study would. The data is generated directly from laboratory testing and quality control processes.
4. Adjudication Method for the Test Set:
- Not applicable. As the tests are objective measurements, there is no need for expert adjudication in the traditional sense (e.g., comparing expert reads to an algorithm's output). The results are determined by adherence to pre-defined numerical or qualitative standards (e.g., "no primary skin irritant reactions," "meets requirements," "no more than 2 mg powder per glove").
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This type of study is typically performed for diagnostic devices (e.g., AI in radiology) where human readers interpret data, and the AI's impact on their performance is evaluated. This device is a patient examination glove, and the tests relate to its physical properties, barrier function, and biological compatibility, not its interpretation performance.
6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Study Was Done:
- No. This device is a physical product, not an algorithm. Therefore, "standalone algorithm performance" is not relevant. The performance described is the inherent performance of the physical glove itself.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's performance is established by:
- External Standards: Adherence to established industry standards like ASTM-D-5250-00E4 for physical properties and dimensions, and ASTM D6124-06 for residual powder.
- Regulatory Requirements: Meeting FDA's 1000 ml. Water Fill Test requirements for barrier integrity and general 21 CFR references for biocompatibility.
- Direct Laboratory Measurements/Observations: Results from primary skin irritation and sensitization tests (direct observation of biological response).
- Predicate Device Equivalence: The ultimate "ground truth" for market clearance is demonstrating substantial equivalence to a legally marketed predicate device (K000071) where those benchmarks established its safety and effectiveness.
8. The Sample Size for the Training Set:
- Not applicable. This device is a physical product, not an AI or machine learning model that requires a "training set." The testing described relates to product quality control and performance validation, not algorithm development.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for an algorithm, this question is not relevant to the described device and studies.
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EXHIBIT #1 Page 1 of 2
510(K) SUMMARY
DEC - 5 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: | K063213 |
|---|---|
| -------------------------------- | --------- |
l . 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. Powder Free (White) Vinyl Patient Examination Gloves
3. Predicate Device Information:
Shijiazhuang Great Eagle Plastic Products Co., Ltd Powder Free (White) Vinyl Patient Examination Gloves (K000071)
4. Device Description:
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free 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 Powder Free (White) Vinyl Patient Examination Gloves is substantially equivalent in safety and effectiveness to the Shijiazhuang Great Eagle Plastic Products Co., Ltd.'s Powder-Free (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 D6124-06 for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove).
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 Powder Free (White) Vinyl Patient Examination Gloves conform fully to ASTM D-5250-00€4 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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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wing shapes, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle emblem.
od and Drug Administration 200 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 - 5 2006
Re: K063213
Trade/Device Name: Ever Light Plastic Products Co., Ltd. Powder Free (White) 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 vour 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 cntitled, "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,
Suitte Y. Michael MD.
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): K 6632) 3 Ever Light Plastic Products Co., Ltd. APPLICANT: Powder Free (White) Vinyl Patient Examination Gloves. DEVICE NAME:
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)
Shale N. Murphy MD
Anesthesiology, General Hos,
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.