(23 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 containation 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 21 C requirements of ASTM standard D-5250-00E4.
This document describes the 510(k) summary for Super Safe Plastic Products Co., Ltd.'s Powdered Vinyl Patient Examination Gloves, White. The summary focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ASTM D-5250-00E4 Standard (Physical & Dimensions) | All testing meets requirements for physical and dimensions testing conducted on gloves. |
| FDA 1000 ml Water Fill Test (Pinhole) | Sampling conducted at AQL 2.5, inspection level I, meeting requirements. |
| Primary Skin Irritation | Testing conducted with results showing no primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis) | Testing conducted with results showing no sensitization reactions. |
| Residual Powder (ASTM D-6124-06 for Starch) | Testing conducted to ensure gloves meet "powdered" claims (contain no more than 10mg/dm2). |
2. Sample Size Used for the Test Set and Data Provenance
The document provides the following information:
- ASTM D-5250-00E4 (Physical & Dimensions): "Inspection level S-2, AQL 4.0." This refers to sampling plans defined within the ASTM standard. The specific sample size is not explicitly stated in the provided text but would be determined by these parameters.
- FDA 1000 ml Water Fill Test (Pinhole): "Samplings of AQL 2.5, inspection level I." Similar to the above, this indicates the sampling plan, but the exact numerical sample size is not presented.
- Primary Skin Irritation and Skin Sensitization: The document doesn't specify sample sizes for these tests.
- Residual Powder Test: The document doesn't specify sample size for this test.
Data Provenance: Not explicitly stated, but based on the manufacturer's location (Shijiazhuang, Hebei, China), the testing was likely conducted in China. The document does not specify if the data is retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The tests performed are objective, laboratory-based tests (e.g., physical measurements, water fill tests, chemical tests, biocompatibility tests). They do not involve expert interpretation or ground truth establishment in the way, for example, a diagnostic imaging study would.
4. Adjudication Method for the Test Set
Not applicable, as the tests are objective and do not require expert adjudication.
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
Not applicable. This is a medical device for personal protection (gloves), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed is based on:
- Established ASTM Standards: For physical properties, dimensions, and residual powder content. These standards define objective criteria and test methods.
- FDA Requirements: For the pinhole test (1000 ml Water Fill Test).
- Biocompatibility Testing Protocols: For primary skin irritation and skin sensitization, which involve established biological assessment methods.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning model and does not involve a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets acceptance criteria is a series of non-clinical tests conducted on the Super Safe Plastic Products Co., Ltd. Powdered Vinyl Patient Examination Gloves, White. These tests were designed to demonstrate compliance with recognized industry standards and regulatory requirements for patient examination gloves.
The key aspects of this study include:
- Compliance with ASTM D-5250-00E4: The gloves were tested for physical and dimensional characteristics, with all results meeting the requirements of this ASTM standard. The sampling plan for these tests was based on "Inspection level S-2, AQL 4.0."
- Pinhole Integrity (FDA 1000 ml Water Fill Test): The gloves underwent the FDA 1000 ml Water Fill Test, meeting the requirements with a sampling plan of "AQL 2.5, inspection level I."
- Biocompatibility Testing:
- Primary Skin Irritation: Tests were conducted, showing no primary skin irritant reactions.
- Skin Sensitization (Allergic Contact Dermatitis): Tests were conducted, showing no sensitization reactions.
- Residual Powder Content: A Residual Powder Test based on ASTM D-6124-06 was performed to ensure the gloves meet the "powdered" claim, meaning they contain no more than 10mg/dm2 of starch.
The conclusions of these tests collectively demonstrated that the device "conform[s] fully to ASTM D-5250-00E4 standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims." The results provided the basis for the FDA's determination of substantial equivalence to the predicate device.
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JAN 2 6 2007
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: K070040
1. 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, White
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 L YZ, and meets all 21 C 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 containation between healthcare personnel and the patient's body, fluids, waste or environment.
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6. Comparison to Predicate Devices:
Super Safe Plastic Products Co., Ltd.'s Powdered Vinyl Patient Examination Gloves, White 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 Super Safe Plastic Products Co., Ltd.'s glove production are based on ASTM-D-5250-00 e4. 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, White 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/ requirencents and 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 and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Super Safe Plastic Products Company, Limited C/O Ms. Kathy Liu Official Correspondent Gloveco, Incorporated 3973 Schaefer Avenue Chino, California 91710
JAN 2 6 2007
Re: K070040
Trade/Device Name: Powdered Vinyl Patient Examination Gloves, White Regulation Number: 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 (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 vours.
Sugite Y. Michie PhD
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
KO70040 510 (k) NUMBER (IF KNOW): APPLICANT: Super Safe Plastic Products Co., Ltd. DEVICE NAME: Powdered Vinyl Patient Examination Gloves, White
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)
Shule 17 M. Murphy, ho
§ 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.