(20 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Powdered Vinyl Patient Examination Gloves:
This document is a 510(k) premarket notification for a Class I medical device (Powdered Vinyl Patient Examination Gloves). For such devices, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are generally based on adherence to recognized standards and non-clinical testing rather than complex clinical studies with human participants. The focus is on demonstrating substantial equivalence to a predicate device and meeting established performance specifications.
1. Table of Acceptance Criteria and 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. |
| Pinhole FDA Requirements (Water Fill Test) | FDA 1000 ml. Water Fill Test conducted with samplings of AQL 2.5, inspection level I, meeting these requirements. |
| Primary Skin Irritation | Results showing no primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis) | Results showing no sensitization reactions. |
| Residual Powder (Starch) (based on ASTM D-6124-06) | Conducted to insure gloves meet "powdered" claims (contain no more than 10mg/dm2). |
| Biocompatibility (General) | Meets biocompatibility requirements (implied by skin irritation/sensitization tests). |
| Labeling Claims | Meets labeling claims (no special claims, not hypoallergenic). |
2. Sample Size Used for the Test Set and Data Provenance
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Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The exact number of gloves tested is not specified but is determined by the AQL (Acceptable Quality Limit) standard for lot inspection.
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FDA 1000 ml. Water Fill Test: Samplings of AQL 2.5, inspection level I. The exact number of gloves tested is not specified, but indicated by the AQL standard.
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Primary Skin Irritation and Skin Sensitization Testing: The sample size for these tests (e.g., number of animals or human volunteers if applicable) is not specified in the document.
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Residual Powder Test: Not explicitly stated, but performed at "finished inspection" based on ASTM D-6124-06.
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Data Provenance: The document does not explicitly state the country of origin of the data (e.g., where the independent labs for skin testing were located). However, the manufacturing company is "Super Safe Plastic Products Co., Ltd." located in Shijiazhuang, Hebei, China. The testing would likely have been conducted in China or by labs contracted by the Chinese manufacturer.
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Retrospective or Prospective: These tests are prospective in nature, conducted specifically to demonstrate compliance for this device prior to submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable in the traditional sense for this device. For Class I general-use products like examination gloves, "ground truth" is established by adherence to recognized consensus standards (like ASTM standards) and regulatory requirements (like FDA water fill tests).
- The tests are objective measurements against established thresholds, rather than subjective expert consensus on complex findings. For the skin irritation/sensitization tests, these would typically be conducted by qualified toxicologists or dermatologists, but their specific number and qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
- Not Applicable in this context. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where multiple experts review cases to establish a "ground truth" for diagnostic or prognostic endpoints.
- For these gloves, the "ground truth" is compliance with objective, quantifiable thresholds defined by ASTM standards and FDA test methods. The tests themselves are the "adjudicators" against a set standard.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is not relevant or required for a Class I patient examination glove. These studies are typically used to assess the impact of a diagnostic AI algorithm on human reader performance, which does not apply here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This device is a physical product (gloves), not an AI algorithm. Therefore, "standalone algorithm performance" is not a concept that applies.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- Industry Consensus Standards: Primarily ASTM D-5250-00E4 for physical and dimensional properties, and ASTM D-6124-06 for residual powder.
- Regulatory Requirements: FDA's 1000 ml Water Fill Test for pinholes.
- Biological Compatibility Testing Guidelines: Standard methods for assessing primary skin irritation and skin sensitization.
These act as the objective benchmarks against which the device's performance is measured.
8. The Sample Size for the Training Set
- Not Applicable. This is a hardware medical device, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, this question is not applicable.
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EXHIBIT #1 Page 1 of 2
510(K) SUMMARY
JAN 2 3 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.
kol 0035 The assigned 510(K) number is:
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
3. Predicate Device Information:
Shijiazhuang Great Eagle Plastic Products Co., Ltd Powdered Vinyl Patient Examination Gloves (K983645)
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:
Super Safe Plastic Products Co., Ltd.'s Powdered 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
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 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 seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. (USA)" arranged in a circular pattern.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 2007
Super Safe Plastic Products Company, Limited C/O Ms. Kathy Liu Gloveco, Incorporated 3973 Schaefer Avenue Chino, California 91710
Re: K070035
Trade/Device Name: Powdered Vinyl Patient Examination Glove 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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
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:
Super Safe Plastic Products Co., Ltd. Powdered Vinyl Patient Examination Glove.
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)
Sheila A. Murphy, MD
a Arta ... Residiogy, General Hospits Control, Bental 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.