(51 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-5250-00€4.
The provided text describes a 510(k) submission for powdered vinyl patient examination gloves. As such, it is not a study about a software-based AI/ML driven medical device, and therefore the requested information regarding acceptance criteria and studies tailored to such devices is largely inapplicable.
The document focuses on demonstrating substantial equivalence to a predicate device for a physical medical device (gloves). The typical performance metrics, study designs (e.g., MRMC, standalone), and ground truth establishment methods for AI/ML devices are not relevant here.
However, I can extract the information that is provided and explain why other requested details are not present.
Inapplicability Note:
The provided text describes the regulatory filing for a physical medical device (powdered vinyl patient examination gloves) and not a software-based AI/ML device. Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth) are not applicable to this type of device and are not detailed in the provided 510(k) summary. The "acceptance criteria" here refer to conformance with established standards for physical properties and safety, not statistical performance metrics of an algorithm.
Extracted Information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance (Compliance) |
|---|---|---|
| Physical and Dimensions | ASTM-D-5250-00E4 | Meets all requirements, Inspection Level S-2, AQL 4.0 |
| Pinhole/Water Leak Test | FDA 1000 ml. Water Fill Test | Meets requirements, AQL 2.5, Inspection Level I |
| Biocompatibility (Irritation) | Primary Skin Irritation Test | No primary skin irritant reactions |
| Biocompatibility (Sensitization) | Skin Sensitization Test (allergic contact dermatitis) | No sensitization reactions |
| Residual Powder | ASTM D-6124-06 for Starch | Meets "powdered" claims (contains no more than 10mg/dm2) |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set:
- Physical and Dimensions: Inspection Level S-2, AQL 4.0 (specific sample size from lot not provided, but these are standard sampling plans).
- Pinhole/Water Fill Test: AQL 2.5, Inspection level I (specific sample size from lot not provided, but these are standard sampling plans).
- Biocompatibility: Not explicitly stated how many subjects/samples were used, but standard tests were conducted.
- Residual Powder: Not explicitly stated how many samples were used, but conducted at finished inspection.
- Data Provenance: Not explicitly stated, implied to be laboratory testing conducted by or for Super Safe Plastic Products Co., Ltd. (China). Retrospective for the purposes of this submission, as the tests were performed prior to submission.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
- Not Applicable. For a physical device like examination gloves, "ground truth" as understood in AI/ML performance studies does not apply. Performance is assessed against established physical and chemical standards and biocompatibility tests.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods are relevant for subjective interpretations (e.g., image reading) in AI/ML studies. Here, compliance is determined by objective measurements and standardized tests against predefined criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This type of study is for evaluating AI assistance to human readers, which is not relevant for a physical examination glove.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not Applicable. This device is not an algorithm. Performance is inherent to the physical product and its manufacturing process.
7. Type of Ground Truth Used
- Established Standards/Objective Measurements: For aspects like physical dimensions, pinhole defects, residual powder, the "ground truth" is adherence to predefined specifications within recognized industry standards (ASTM D-5250-00E4, ASTM D-6124-06) and regulatory requirements (FDA Water Fill Test). For biocompatibility, it's the observed biological response to the product in standard tests.
8. Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device; therefore, there is no "training set." The manufacturing process involves continuous quality control and testing against established product specifications.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.
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FEB 2 3 7007
EXHIBIT #1 Page 1 of 2
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: K070042
l . Submitter's Identification:
Mr. Lu Wenxin Super Safe Plastic Products Co., Ltd. Meng Er Village, Pingshan County, Shijiazhuang, Hebei, China 050401
Date Summary Prepared: September 20, 2006
2. Name of the Device:
Super Safe Plastic Products Co., Ltd. Powdered Vinyl Patient Examination Gloves, Yellow
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-5250-00€4.
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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1<070042
EXHIBIT #1 Page 2 of 2
6. Comparison to Predicate Devices:
Super Safe Plastic Products Co., Ltd.'s Powdered Vinyl Patient Examination Gloves, Yellow 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 Super Safe 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:
Super Safe Plastic Products Co., Ltd.'s Powdered Vinyl Patient Examination Gloves, Yellow 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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DEPARTMENT OF HEALTH & HUMAN SERVICES · USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Super Safe Plastic Products Company Limited C/O Ms. Kathy Liu Gloveco, Incorporated 3973 Schaefer Avenue Chino, California 91710
FEB 2 3 2007
Re: K070042
Trade/Device Name: Powdered Vinyl Patient Examination Gloves, Yellow Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: December 28, 2006 Received: January 3, 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 (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,
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): KO70042
APPLICANT: DEVICE NAME: Super Safe Plastic Products Co., Ltd. Powdered Vinyl Patient Examination Gloves, Yellow
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 X
(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)
Shula H. Murphy, R
n Sign-Off sion of Are sthesiology, General Hospital on Control, Der
510(k) Number. K170642
§ 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.