(63 days)
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-5250-00€4.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the medical device:
The provided document describes the 510(k) summary for "Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd. Powdered (Yellow) Vinyl Patient Examination Gloves." This is a regulatory filing for a Class I medical device, which typically involves demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical efficacy studies in the same way a novel high-risk device would.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing (ASTM-D-5250-00E4) | All testing meets requirements |
| Inspection level S-2, AQL 4.0 | All testing meets requirements |
| Pinhole FDA Requirements (FDA 1000 ml. Water Fill Test) | Meets requirements with AQL 2.5, inspection level I |
| Biocompatibility (Primary Skin Irritation) | No primary skin irritant reactions |
| Biocompatibility (Skin Sensitization / Allergic Contact Dermatitis) | No sensitization reactions |
| Residual Powder (ASTM D-6124-06) | Meets required claims (no more than 10mg/dm2) |
| Labeling | No special labeling claims; not claimed as hypoallergenic |
| Safety/Efficacy Issues | No safety/efficacy issues or new claims |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions specific inspection levels and AQLs (Acceptable Quality Levels) for certain tests, which imply statistical sampling.
- Pinhole FDA 1000 ml. Water Fill Test: AQL 2.5, inspection level I.
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0.
- Residual Powder Test: Based on ASTM D-6124-06.
The exact number of units sampled for each test is not explicitly stated as a single "sample size" in this document, but rather referred to by AQL and inspection levels, which are methods for determining sample size based on lot size in quality control.
Data Provenance: The tests were conducted on gloves produced by Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd. in China. The study is inherently prospective in the sense that the manufacturer performs these tests as part of their quality control and regulatory submission for the specific device being produced to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- No external "experts" were used to establish ground truth in the context of comparative clinical evaluation for the acceptance criteria listed.
- The nature of these acceptance criteria (physical properties, biocompatibility, pinhole integrity, residual powder) means that the "ground truth" is established by adherence to pre-defined ASTM standards and FDA test methods. The performance is measured against these objective standards.
- The tests themselves would have been conducted by technicians or laboratory personnel, but their qualifications are not detailed, nor are they "experts" establishing a ground truth in the sense of clinical interpretation.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where multiple human readers interpret data (e.g., images) and their disagreements need to be resolved to establish a consensus ground truth. For the physical and chemical tests described here, the results are objective measurements against established standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study was done. This type of study is not relevant for patient examination gloves, which are assessed based on their physical properties, barrier integrity, and biocompatibility, not on their interpretive performance or human reader interaction with an AI system.
6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done
Not applicable. This device is a physical product (gloves) and does not involve an algorithm or AI. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The ground truth used for these acceptance criteria is based on:
- External Standards and Test Methods: Primarily ASTM standards (D-5250-00E4, D-6124-06) and FDA test methods (e.g., 1000 ml. Water Fill Test).
- Objective Measurements: These standards define measurable properties (e.g., tensile strength, elongation, dimensions, pinhole count, residual powder quantity).
- Biocompatibility Testing Protocols: Standardized animal or in-vitro tests for skin irritation and sensitization.
8. The Sample Size for the Training Set
Not applicable. This is a conventional medical device (gloves), not an AI/ML powered device. There is no "training set." The manufacturing process itself could be considered "trained" through quality control and adherence to standards over time, but not in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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EXHIBIT #1 Page 1 of 2
510(K) SUMMARY
MAR 0 7 2007
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. Li Quanfu Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd. Nanwuhui Village, Yuanshi County, Shijiazhuang, Hebei, China 051130
Date Summary Prepared: September 20, 2006
2. Name of the Device:
Shijiazhuang Lianhe Shunda 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 LYZ, and meets all requirements of ASTM standard D-5250-00€4.
5. Intended 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.
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6. Comparison to Predicate Devices:
Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd.'s Powdered (Yellow) Vinyl 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 Shijiazhuang Lianhe Shunda 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:
Shijiazhuang Lianhe Shunda 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 shows the logo for the Department of Health and Human Services (HHS). The logo features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shijiazhuang Lianhe Shunda Plastic Products Company, Limited C/O Ms. Kathy Liu Official Correspondent Gloveco, Incorporated 3973 Schaefer Avenue Chino, California 91710
MAR 0 7 2007
Re: K070026
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: February 15, 2007 Received: February 16, 2007
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,
Snyte y. Mchian Davis.
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:
Shijiazhuang Lianhe Shunda 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 V (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)
Shule. H. Meryling, K.
CERTIFIED TRUE COPY
K07226
§ 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.